Getinge is recalling the Cardiohelp Emergency Drive due to a possible blocking or impairment of the ability of the emergency drive to be cranked. 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. Use of these devices may cause serious injuries or death. There have been no reports of death or injuries associated with this issue.
Getinge sent customers a letter asking them 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 and ensure that an alternate means of emergency support is available at all times, which may include a non-affected 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 to arrange for the return of impacted devices and to receive loaner devices.
- Share this information to 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.
- Complete and sign the attached response form to acknowledge receipt of this notification. Completed forms should be returned to Getinge by emailing a scanned copy to [email protected] or by faxing the form to 1-866-351-3477.
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.