CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Report
- Report Number
- 3003306248-2024-04400
- Event Type
- Malfunction
- Date Received
- August 11, 2024
- Date of Event
- July 24, 2024
- Report Date
- October 7, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140702
- PMA / PMN Number
- K131179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN M4: MOTOR ALARM WITH A RATTLING SOUND WAS CONFIRMED VIA THE CENTRIMAG MOTOR¿S EVALUATION, AND IT WAS DETERMINED THAT THE CONSOLE WAS UNRELATED TO THE CAUSE OF THE EVENT. THE RETURNED CENTRIMAG CONSOLE (SERIAL NUMBER (B)(6) WAS FUNCTIONALLY TESTED AT THE SERVICE DEPOT AND PERFORMED AS INTENDED THROUGHOUT ALL TESTING. THE CONSOLE WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL TESTS PER PROCEDURE. THE ROOT CAUSE OF THE REPORTED EVENT WAS ISOLATED TO AN ISSUE WITH THE CENTRIMAG MOTOR AND WAS NOT CORRELATED TO AN ISSUE WITH THE CONSOLE. REVIEW OF THE DEVICE HISTORY RECORD FOR CENTRIMAG CONSOLE, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH 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 / 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." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS REPORTED THAT THE PERFUSIONIST PRIMED THE CENTRIMAG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITHOUT ISSUE AND THEN CLAMPED THE LINE AT AN RPM GREATER THAN 2000. AN M4 ALARM OCCURRED AND THE CENTRIMAG MOTOR STARTED MAKING A SIGNIFICANT RATTLING NOISE. THE PERFUSIONIST CLAMPED, REMOVED, AND RESEATED THE PUMP WITH NO IMPROVEMENT. THE M4 ALARM WOULD NOT SILENCE OR CLEAR. THE MOTOR AND CONSOLE WERE EXCHANGED. THIS OCCURRED BEFORE THE CENTRIMAG WAS ON A PATIENT.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE ALARMS RESOLVED FOLLOWING THE MOTOR AND CONSOLE EXCHANGE. THE DISPOSABLE PUMP HEAD WAS NOT EXCHANGED AND WORKED JUST FINE WITH THE NEW EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1779821 | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS | QNR | THORATEC SWITZERLAND GMBH | 201-90411 | 7929109 | 07640135140702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |