CENTRIMAG BLOOD PUMP
Report
- Report Number
- 3003306248-2024-04409
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 6, 2024
- Report Date
- November 25, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140627
- PMA / PMN Number
- K020271
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
A1-A6: NO PATIENT INVOLVEMENT D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
B5: ADDITIONAL INFORMATION. H6: UPDATED CODES. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE ROOT CAUSE OF THE REPORTED EVENTS WAS DETERMINED TO BE RELATED TO THE CENTRIMAG MOTOR; THERE WERE NO DEVICE ISSUES WITH THE CENTRIMAG PUMP. THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. NO SPECIFIC ADVERSE EVENTS WERE REPORTED; HOWEVER, THE CENTRIMAG BLOOD PUMP IFU PROVIDES A LIST OF ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM OPERATION MANUAL IS CURRENTLY AVAILABLE. SECTION 4 ENTITLED "WARNINGS & PRECAUTIONS" WARNS ¿ONE ADDITIONAL CENTRIMAG CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP COMPONENTS IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIMAG PUMP IS USED. THE BACKUP CONSOLE MUST BE CONNECTED TO THE BACKUP MOTOR AND TO THE BACKUP FLOW PROBE, HAVE A BATTERY CHARGE SUFFICIENT FOR AT LEAST ONE HOUR OF OPERATION, BE CONNECTED TO AC POWER (EXCEPT DURING TRANSPORT) AND BE IMMEDIATELY AVAILABLE SHOULD THE MAIN CONSOLE, MOTOR OR FLOW PROBE EXPERIENCE A MALFUNCTION.¿ SECTION 12.1 ENTITLED "APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS AS WELL AS THE APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND OPERATION MANUAL CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PUMP SPEED WOULD NOT INCREASE AND WOULD ONLY CHATTER AND MAKE CLICKING SOUNDS. THE DEVICE WAS TAKEN OUT OF SERVICE.
IT WAS LATER NOTED THAT THIS WAS A MOTOR PROBLEM, NOT A PUMP PROBLEM. THE CENTRIMAG PUMP WAS USED WITH ANOTHER MOTOR WITHOUT ANY PROBLEMS. IT WAS USED TO DO A FULL VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO), WITHOUT ANY ISSUES. THE PATIENT WAS NOTED TO BE SURVIVING, AND IT APPEARED THAT THEY WOULD HAVE A GOOD PROGNOSIS.
IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25592 | CENTRIMAG BLOOD PUMP | BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE | QNR | THORATEC SWITZERLAND GMBH | 102953 | 07640135140627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 MO | Male |