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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.
