CENTRIMAG MOTOR, US
Report
- Report Number
- 3003306248-2024-04405
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 6, 2024
- Report Date
- May 11, 2026
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140078
- PMA / PMN Number
- K020271
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A1-A4: PATIENT INFORMATION NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
H4 - DEVICE MANUFACTURE DATE: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A M4 ALARM WAS NOT CONFIRMED. ADDITIONAL INFORMATION PROVIDED COMMUNICATED THAT PRODUCTS WOULD BE RETURNED FOR ANALYSIS; HOWEVER, TO DATE NO PRODUCTS HAVE BEEN RETURNED. IF ANY PRODUCTS ARE RETURNED AT A LATER DATE, THIS FILE WILL BE REOPENED WITH FURTHER ANALYSIS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE CENTRIMAG MOTOR, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CENTRIMAG MOTOR WAS SHIPPED TO THE CUSTOMER ON 03JUN2021. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 10 ¿ ¿EMERGENCIES/TROUBLESHOOTING¿ PROVIDES INSTRUCTIONS FOR OPERATION WHEN THERE IS A NEED TO EXCHANGE THE MAIN CONSOLE OR MOTOR WITH A BACKUP CONSOLE OR MOTOR. THE RECOMMENDED PRACTICE WHENEVER THERE IS A 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 BACK-UP MOTOR AND CONSOLE. SWITCH ALL COMPONENTS (CONSOLE, MOTOR, FLOW PROBE AND CABLES) SIMULTANEOUSLY TO CONTINUE PATIENT SUPPORT, AND THEN PERFORM TROUBLESHOOTING ON THE NON-FUNCTIONING SYSTEM, WHEN IT IS NO LONGER BEING USED FOR PATIENT SUPPORT. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 12.1 ¿ "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING MOTOR ALARMS, AND THE APPROPRIATE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. CENTRIMAG MOTOR INSTRUCTIONS FOR USE 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.
IT WAS REPORTED THAT THE CUSTOMER HAD AN M4 ALARM WHEN UTILIZING ONE OF THEIR CENTRIMAG MOTORS. THE MOTOR WAS REPLACED WITH A DIFFERENT ONE.
IT WAS ADDITIONALLY REPORTED THAT THE ALARM OCCURRED DURING THE SETUP AND PRIMING PHASE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311529 | CENTRIMAG MOTOR, US | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS | QNR | THORATEC SWITZERLAND GMBH | 102956 | 7929106 | 07640135140078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |