In August 2023, FDA recall was published, due to a defect in emergency drive of the Cardiohelp console.
In some
units. emergency drive may get stuck.
In situations where the emergency
drive is required, a clinician may encounter difficulty turning the handle to
operate the pump or may not be able to turn it at the required speed to
adequately support the patient. If such challenges arise, the patient may
experience a loss of sufficient hemodynamic support or gas exchange, leading to
potential consequences like ischemia, hypoxia, stroke, or even death.
The measuresto be taken are: Promptly inspect your
existing inventory to identify any CARDIOHELP Emergency Drives that may be
affected, notify Getinge immediately and ensure that an alternative emergency
support method is readily available at all times.
• Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns [Link]
• Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns [Link]
Screen
issues in the heartmate system monitor. June 2024.
The
HeartMate System Monitor is a component of the HeartMate Left Ventricular
Assist System. The System Monitor is used in the operating room or during
clinic visits to...
•Closely monitor system operation
during lvad implant
•Display information about system
performance, including current operating mode, pump flow, pump speed, and
overall operational status
•Program system parameters such as
pump speed
•Assess and track alarm conditions
•View and save performance data
•And record data at specific
intervals for review and analysis
The
company has alerted about an irregular behavior of the monitor screen.
These
issues include screen freezing, overlapping buttons or screens, unresponsive
buttons, distorted text or graphics, and incorrect or missing information on
the display.
These
problems can lead a clinician to unintentionally change pump settings or press
the pump stop button.
We invite everybody to watch our youtube video for detailed and expanded information:
Male 55yo, familial DCM, with ICD. Admitted to ER with arrhytmic storm and shock. #ECMO iniciated. 3h later, arterial line without pulsatility. TOE performed.
Over the years IABP cath has evolved. First design direct into aorta. Arteriotomy and percutaneous insertion were possible in the next models. Double lumen, bore reduction and fiberoptic sensor were subsequently developed.
First models bulky, gradually improved in terms of autonomy and monitoring. Latest models are more compact and have extended autonomy to enable prolonged interhospital transports.
· Heartmate 3 Implant kit Leakage Risk during LVAD surgery.
FDA Recall.
May 2024.
Abbott is recalling HM3 implant kit after complaints about blood leakage or air entering seal interface between LVAD inflow cannula and apical cuff.
All reported incidents occurred during the device's implantation.
Risks: Blood leakage or air entry at this site can compromise blood flow integrity, potentially leading to extended surgery, bleeding (hemorrhage), right heart failure, or air embolism.
The company issued an Urgent Medical Device Correction Notification letter advising the following:
1. Completely evacuate residual air from the device blood chamber before initiating LVAD support.
2. Use conventional strategies for addressing air leaks or surgical bleeding: adjusting the pump position, reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff or pump as needed.
3. Always have a complete backup system (implant kit and external components) readily available on-site during the implantation procedure for emergency use.
The history of the IABP begins with Kantrowitz's experiments on diastolic augmentation in 1952. He hypothesized that perfusing the coronary bed with systolic blood pressure during diastole would enhance coronary blood flow.
Impella Left Sided Blood Pumps are used for short term support of the left ventricle during high risk pci or cardiogenic shock. At present, the Impella CP and the Impella 5.5 models are the devices available for use. Abiomed recalls the IFU due to perforation risks.
This event may cause serious adverse health consequences, including:
· Left ventricle perforation
· Free wall rupture
· Hypotension
· Tamponade
· Death
The company's recommendations are:
A. For Impella CP
1. Inlet position should be 3.5cm below aortic plane
2. During PCI be aware if the pump shifts deeper
3. Fix the catheter using Tuohy-Borst valve...
4. If a deeper position is noted, PCI should be paused and Impella pulled back.
5. Prior to leaving the cath-lab position should be confirmed with echo...
B. For Impella 5.5
1. Inlet position 5cm below aortic plane...
2. Consider reposition to a temporary shallower position (3.5cm) during surgery.
3. Especial caution during heart manipulation during surgery.
C. For both Impella CP and Impella 5.5
1. Use imaging when advancing or torquing the pump catheter...
The ECMO cannulas are the drainage or return tubes inserted into the patient's anatomy.
They are usually made of PVC or PU, materials that give the appropriate consistency, flexibility and resilience (ability to recover its initial shape after clamping).
The cannulas typicallyincorporate a "wired" zone to prevent kinking, and for radiographic visualization.
The walls of the cannulas are thin to maximize the internal diameter.
They are generally coated with products in their lumen, making them more biocompatible (variable between companies).
They play a significant role in determining the circuit's capacity to deliver adequate flow and support, frequently serving as a limiting factor.
The HM Touch is a tablet specifically dedicated to connect to HM2/HM3 and:
1. Display information about system performance.
2. Program system parameters.
3. Assess and track alarms.
Abbott has received notifications regarding issues with Heartmate (HM) Touch due to inappropriate stopping of the pump.
Unexpected pump stop could result in hemodynamic compromise or syncope.
The company has reported that incidents occurred when the "Stop Pump" sequence was activated and communication was disrupted before the "Stop Pump" sequence was completed.
If communication is interrupted, “Stop Pump” sequence stay in the App’s queue. When a new HM2/HM3 connects to HM Touch, communication resumes, triggering the “Stop Pump” command.
This results in the LVAD starting if it was not running, or in the LVAD stopping if running at the time of connection.
This issue has been detected in version 1.0.32 of the HM Touch app.
The company has informed customers, and recommendation is as follows:
1. Do not disconnect the HM2/HM3 system controller until "Stop Pump" sequence screen with the red progress bar is over.
2. When the process is completed, the screen automatically changes to the one presented in the figure.
In January 2024, Abiomed issued a safety alert regarding the purge retainer.
The company received field complaints, regarding fractured blue purge retainers in the AIC (Automatic Impella Console)
A thorough analysis of these failures revealed that consoles manufactured 4 or more years ago are more prone to purge assembly failure, and age likely contributes to material weakening of the purge disc retainer within the pressure sensor assembly
It may be also related with harsh cleaning agents and dextrose buildup from purge cassette leaks.
If the purge retainer is damaged, the AIC may not be able to recognize the connection of the purge disc, rendering the AIC unable to be used for Impella support
Abiomed recommendations are:
1. Carefully inspect the purge retainer assembly for any damage before support.
If damage is noticed, verify system functionality.
If functionality is compromised, report a complaint and return the console to the company.
Clean the assembly according to hospital protocol, as well as following any potential exposure to dextrose after a purge leak.
During cleaning, avoid products containing Isopropyl Alcohol or bleach.
To correctly change out a purge cassette, avoid removing a purge disc while the system is pressurized. Disconnect the yellow luer lock before removing the purge disc.
It could be said that the Impella heart pump catheter is derived from the machine designed by Archimedes in Alexandria, in the 3rd century BC: the Archimedes screw.
This is a summary, detailed and expanded information in this video:
This machine was a positive displacement pump, and not really an axial pump.
Irrigation systems based on Archimedes' screw have persisted in some regions of the world, as Egypt.
In 1976, doctor Richard Wampler, from USA, visited Egypt, and this irrigation mechanism caught his attention.
Returning home, got involved in the design of artif hearts. Using the idea, but with impeller, his team developed the Hemopump. Introduced through femoral artery, powered by external motor, it could provide flow of 3 to 4 L/min.
However, Hemopump failed to success and was discontinued. Fortunately, the principles persisted. In 1991, Siess et al, in Aachen, Germany, initiated modifications to enhance the Hemopump design: redesigned impeller and motor into the catheter itself.
Impella Cardiotechnik was founded in December 1997. This small company developed successful pilot animal experiments with Impella, and obtained CE-label in 1999 for intraoperative use.
Finally, in 2005, after developing diverse products and numerous patents, the company was acquired by the American medical technology firm Abiomed.
In December 2023, Getinge issued a safety alert regarding an potential insufficient packaging sterility of the emergency priming line.
Getinge informed of an issue related to HLS Sets that may affect the sterile barrier of the Emergency priming line.
The Emergency priming line is employed to remove air from from the membrane, only used in emergency situations.
During internal testing, it were discovered narrow channels in the sealing of the sterile bag of Emerg. Prim. Line, this could lead to a breach in the sterile barrier.
The aforementioned bag, is packed in the sterile tray with the rest of the HLS Set.
The company says that even with the potentially compromised sterile bag, the emergency priming line is sterile when opening an HLS Set for the first time.
If Emergency priming line is needed later, a new HLS Set should be opened to obtain a sterile emergency priming line.
The use of a non sterile line could expose patients to pathogens and lead to the following potential damages:
•Inflammation
•Infection
•Sepsis
The company has already taken action, informing its customers about the affected batches and the measures to be taken.
The recommendations are:
· Discard the Emergency priming line (EPL) from the affected HLS Set
· If necessary, use the (EPL) from a spare HLS Set
· Discard the remaining components of spare HLS Set
· Contact the company to replacement HLS Set or reimbursement.
How to use Flowtriever during ECMO? Cautions during ECMO and Flowtriever?
Flowtriever has been reported treatment for PE in cases on VA-ECMO with some favorable outcomes in this setting improving RV function and facilitating ECMO weaning. However, some advices must be taken into account.
This is a summary, detailed and expanded information in this video:
AIR EMBOLISM can occur.
The advice to prevent this event is clamp/decrease ECMO flow (1lpm) during:
-- FlowTriever passage through IVC
-- Aspirations
-- Opening of dryseal valve
-- Passage of dilator-guidewire
THROMBUS ASPIRATION towards the ECMO device through the drainage cannula, especially in the case of the "lollipop effect." To prevent this problem, it is advisable to clamp ECMO while Flowtriever is being removed from the patient.
On 2023, Getinge voluntarily issued a safety notice regarding intra-aortic balloon pump catheters.
The problem affects the insertion kit.
On occasions, the sheath fractures at the connector, leaving the dilator body lodged inside the sheath. If this event occurs during IABP catheter insertion, the sheath and dilator assembly should be removed. Surgical extraction may be necessary at times.
The company's recommendations are as follows:
a) Insertion can be performed using alternative sheath.
Ideally reinforced with wire and 1 French diameter larger than the IABP catheter and a length of 10-15.2cm.
b) IABP catheter insertion with the sheathless technique.
OR
c) Return the IABP catheter along with its insertion kit to the company.
In November 2023, Maquet/Getinge released a safety note about the venous probe.
The venous probe of the CARDIOHELP system measures venous oxygen saturation, hemoglobin, hematocrit, and venous temperature. The venous probe cable, is the subject of this Security Alert.
A notably number of breaks in the insulation sheath and the shielding of the cable has been observed.
The fracture may impact the control of extracorporeal support due to the lack or incorrect values communicated.
The potential health consequences may include any of the following complications:
The measure taken by the company is the localization and replacement of the of the venous probe cable for the CARDIOHELP system.
Fig 1. ECMO Cardiohelp venous probe with insulation defect.
In August 2023 FDA published a recall about maquet/Getinge IABP consoles.
The company issued a recall for the Cardiosave Hybrid IABPs due to the possibility of unexpected shutdowns caused by failures in the printed circuit board assembly (PCBA) within the charging path circuit.
If this situation arises, the device might lose its ability to charge batteries in one or both battery slots.
Using an affected pump could lead to severe negative health outcomes in patients with hemodynamic inestability.
The recommendations are:
• Not removing the battery when it's at 80% charge or above and actively charging.
• If absolutely necessary to remove the battery before full charge:
- Attach the IAB catheter to an alternate IABP console.
- Turn off the Cardiosave, disconnect from AC, extract the battery.
In August 2023 FDA published a Recall about Maquet/Getinge consoles.
The Company issued a recall for the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as they might experience sudden shutdowns due to electrical issues in the Power Unit.
This issue could lead to a loss of hemodynamic support, which in patients highly dependent on it could result in hemodynamic instability and clinical deterioration.
Typically, the problem is resolved by restarting the console within 1-2 minutes and restoring the parameters.
In any case, the company recommends having a backup console available at all times or providing alternative hemodynamic support (we understand this refers to vasoactive drugs, Impella, ECMO, or Tandem-Heart).
In June 2023 FDA published a recall about impella left sided pumps and TAVI.
This was actually a voluntary correction by the company. The notice affects the currently available left ventricular assist devices, primarily Impella CP and Impella 5.5. Impella heart pumps.
There is a possibility that the Impella motor housing might make contact with the distal stent of a transcatheter aortic valve replacement (TAVR). This contact could lead to damage or destruction of the motor's impeller blades.
If the Impella system is damaged, it could result in reduced blood flow or pump failure, potentially leading to insufficient support. This could be life-threatening, especially for individuals who require high levels of support.
Additionally, there is a concern that broken blade fragments could cause systemic embolization.
The company's advice to prevent complications in this setting is as follows:
• Be mindful of the potential interaction between the Impella system and TAVR.
• Take extra care when positioning the Impella system in patients with TAVR.
• Avoid repositioning the device while it is spinning.
• Switch the device to P0 mode during repositioning or any movement that might bring the outlet windows close to the valve stent structures.
• If low flow is observed in a patient who has undergone TAVR and is on Impella heart pump support:
In April 2023, FDA published a recall about Impella 5.5.
Impella 5.5 is the Impella heart pump with the maximum blood flow.
In case of a purge leak, the system will encounter reduced purge pressures, triggering alarms and necessitating assessment. If the leak problem remains unresolved, continuous low purge pressure and purge flow could result in the pump shutting down, leading to the loss of therapy.
The company advises using water for cleaning. It is essential to avoid using sterilization solutions containing isopropyl alcohol (like ChloraPrep or Hibiclens) on the purge system.
The reason is that isopropyl alcohol could potentially weaken or damage these components of the Impella purge system.
In March, 2023, The FDA issued an alert regarding a potential sterility issue in the packaging of the disposable component of the Maquet Cardiohelp system, which includes the oxygenator, heat exchanger, and centrifugal pump. The company identified a gap in packaging validation testing that could compromise sterility.
Being exposed to a medical device that is not sterile can lead to health effects such as inflammation, infection, sepsis, or ischemia.
Measures were taken to correct this issue, and an informative letter is included in each package. Prior to using the set, a visual examination of the packaging should be conducted to look for signs of stress marks, flaws, or any damage.
We invite you to watch our video with extended information about this issue:
