CENTRIMAG MOTOR, US
Report
- Report Number
- 3003306248-2024-04408
- 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
- 07640135140078
- PMA / PMN Number
- K020271
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
A1-A6: NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
D4 - PRIMARY UDI NUMBER, UPDATED. H5 - LABELED FOR SINGLE USE?: CORRECTED. H6 - MEDICAL DEVICE PROBLEM CODE: CORRECTED. H8 - USAGE OF DEVICE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG MOTOR NOT FUNCTIONING AS INTENDED WAS CONFIRMED. THE CENTRIMAG MOTOR (SERIAL NUMBER: (B)(6)) WAS RETURNED FOR ANALYSIS TO THE SERVICE DEPOT AND WAS CONNECTED TO A TEST CENTRIMAG CONSOLE AND MOCK LOOP. DURING TESTING THE REPORTED EVENT WAS CONFIRMED. AN AUDIBLE ALARM BECAME ACTIVE, AND THE CONSOLE DISPLAYED A MOTOR ALARM: M4 AND SET PUMP SPEED NOT REACHED: M5. THE IMPELLER BEGAN TO VIBRATE WITHIN THE MOTOR. THE MOTOR WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. THE RETURNED MOTOR WAS CONNECTED TO A TEST MONITOR, TEST CONSOLE AND MOCK LOOP. THE MOTOR CABLE WAS FLEXED AND A MOTOR ALARM: M4 AND SET PUMP SPEED NOT REACHED: M5 APPEARED. THE UNDERLYING WIRES OF THE MOTOR WERE MEASURED, AND AN OPEN LOOP WAS OBSERVED BETWEEN THE FILED SIGNAL FOR THE BX AND BY DIRECTION. THE MOTOR CABLE LEMO CONNECTOR WAS OPENED, AND THE GREY SIGNAL WIRE WAS FOUND TO NOT BE PROPERLY SOLDERED TO THE LEMO CONNECTOR. NO FURTHER TESTING WAS PERFORMED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO AN IMPROPER SOLDER CONNECTION AT THE MOTOR LEMO CONNECTOR. A PREVIOUS MANUFACTURING TASK INVESTIGATED THIS ISSUE AND RESULTED IN OPENING A NON-ISSUANCE SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) TO INFORM THE SUPPLIER. THIS MOTOR WAS MANUFACTURED PRIOR TO THE INITIATION OF THE SCAR. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG MOTOR (SERIAL NUMBER: (B)(6)) AND THE MOTOR WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 4 ENTITLED "WARNINGS & PRECAUTIONS" WARNS "ONE ADDITIONAL 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP SYSTEM IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIVAS BLOOD 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." THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 10 ENTITLED "EMERGENCY AND TROUBLESHOOTING" STATES THAT "THE RECOMMENDED PRACTICE WHENEVER THERE IS A 2ND GENERATION CENTRIMAG PRIMARY CONSOLE OR MOTOR MALFUNCTION IS TO REPLACE THE CONSOLE AND MOTOR AS A SET. REMOVE THE BLOOD PUMP FROM THE MALFUNCTIONING MOTOR AND CONSOLE AND PLACE THE BLOOD PUMP IN THE BACKUP MOTOR AND CONSOLE TO CONTINUE PATIENT SUPPORT. DO NOT EXCHANGE INDIVIDUAL MOTORS OR INDIVIDUAL CONSOLES DURING PATIENT SUPPORT." THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 12.1 ¿APPENDIX I ¿ CONSOLE ALARMS AND ALERTS¿ TABLE 16 DETAILS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING S3 ALARMS. CENTRIMAG MOTOR IFU INSTRUCTS THE USER TO INSPECT THE CENTRIMAG MOTOR, CABLE, CONSOLE CONNECTOR, AND LOCKING MECHANISM FOR ANY DAMAGE PRIOR TO USE. IF ANY COMPONENT IS DAMAGED, DO NOT USE THE CENTRIMAG MOTOR. THIS DOCUMENT STATES THAT IF THE UNIT FAILS TO OPERATE ACCORDING TO THE MOTOR SPECIFICATIONS OR A CONSOLE DIAGNOSTIC ERROR INDICATES A CENTRIMAG MOTOR MALFUNCTION, IT SHOULD BE RETURNED. ADDITIONALLY, THIS DOCUMENT INSTRUCTS THE USER TO ALWAYS HAVE A SPARE CENTRIMAG MOTOR AND BACK-UP EQUIPMENT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
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 REPORTED THAT THE PATIENT WAS DISCHARGED.
IT WAS LATER REPORTED 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17794 | CENTRIMAG MOTOR, US | BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE | QNR | THORATEC SWITZERLAND GMBH | 102956 | 7270755 | 07640135140078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Male |