Getinge is recalling the Cardiohelp Emergency Drive due to a possible blocking or impairment of the ability of the emergency drive to be cranked, according to a safety communication from the US Food and Drug Administration (FDA).
The emergency drive can become stuck or difficult to turn due to friction being generated in the handle attachment. The stiff hand crank is caused by a scrounger disc that interferes with the turning of the crank.
If the emergency drive is needed, a clinician may not be able to turn the handle to drive the pump or may not be able to turn the handle as fast as is needed to adequately support the patient. If this occurs, the patient will lose adequate hemodynamic support or gas exchange, the results of which could include ischemia, hypoxia, stroke, or death.
The FDA has identified this as a Class I recall, the most serious type of recall. There have been no reports of death or injuries associated with this issue.
The Cardiohelp System helps oxygenate blood and remove carbon dioxide from it. It moves blood through a circuit outside the body to support the heart and lungs for up to six hours. It is also intended to support the heart and lungs during procedures not requiring cardiopulmonary bypass, again for up to six hours.
- Product name: Cardiohelp Emergency Drive
- Product codes: See recall database entry
- Model numbers: 701048002, 701076205
- Manufacturing dates: Aug 11, 2022, through June 20, 2023
- Distribution dates: Sept 14, 2022, to July 27, 2023
- Devices Recalled in the US: 41
Healthcare providers who use the Cardiohelp System to treat patients and people undergoing treatment where the Cardiohelp System is used to support blood flow or oxygen supply may be impacted.
On Oct 5, Getinge sent all affected customers an Urgent Medical Device Removal Notice. The letter requested customers to:
- Immediately examine current inventory to determine if it includes any affected Cardiohelp Emergency Drives.
- If the affected product is currently being used in patient treatment, the customer should inform Getinge immediately at 888-943-8872, option 1, option 1, and ensure that an alternate means of emergency support is available at all times, which may include a nonaffected Emergency Drive (if available) or a fully charged backup Cardiohelp console.
- Ensure that they are contacted by Getinge to arrange for loaner replacement drives where needed and to arrange for the return of the affected Emergency Drives for repair.
- Alternatively, the customer can reach out to Getinge at 888-943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8 am and 6 pm EST to arrange for the return of impacted devices and to receive loaner devices.
- Share this information with all current and potential Cardiohelp users within the hospital/facility.
- Distributors who have shipped any affected products to customers should forward this document to their attention for appropriate action.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.