The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning System CS 100, CS100i and CS 300 Intra-Aortic Balloon Pumps (IABPs), manufactured by Maquet. The affected devices are identified as follows:
- CS100i IABP [Part Number: 0998-UC-0446HXX; 0998-UC-0479HXX]
- CS100 IABP [Part Number:0998-00-3013-XX; 0998-UC-3013-XX]
- CS300 IABP [Part Number: 0998-00-3023-XX; 0998-UC-3023-XX]
- This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.
The manufacturer received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.
The manufacturer indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Affected users are instructed to adhere to the following instructions when using affected devices:
- Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
- An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:
- WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.
- Until the service is performed, the manufacturer recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, affected users should remove the IABP from service and contact the manufacturer.
- A service representative will be replacing the defective solenoid driver boards. Affected users having affected IABP unit(s) will be contacted by the manufacturer to schedule on-site service.
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563615.htm
https://www.fda.gov/Safety/Recalls/ucm563583.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 June 2017