CENTRIMAG MOTOR, US
Report
- Report Number
- 2916596-2024-06227
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Date of Event
- September 11, 2024
- Report Date
- March 12, 2025
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140078
- PMA / PMN Number
- K020271
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
A1-A6: NO PATIENT INVOLVED NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
D3: MANUFACTURER INFORMATION: CORRECTION. D9: DATE RETURNED TO MANUFACTURER: CORRECTION. G1: MANUFACTURING SITE: CORRECTION. H4: DEVICE MANUFACTURE DATE: CORRECTION. H5: LABELED FOR SINGLE USE? CORRECTION. H8: USAGE OF DEVICE: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PUMP NOT SITTING PROPERLY ON THE CENTRIMAG MOTOR ALONG WITH A MOTOR ALARM WAS CONFIRMED. THERE WERE NO LOG FILES SUBMITTED FOR REVIEW. THE SUBMITTED PICTURES SHOW THE M4 MOTOR ALARM, M5 SET PUMP SPEED NOT REACHED, AND S3 SYSTEM ALERT ACTIVE ON THE CONSOLE. THE CENTRIMAG MOTOR, SERIAL (B)(6), WAS EVALUATED AT THE SERVICE DEPOT. THE MOTOR WAS CONNECTED TO A MOCK LOOP AND THE M4 MOTOR ALARM, M5 SET PUMP SPEED NOT REACHED, AND S3 SYSTEM ALERT APPEARED ON THE CONSOLE. THE IMPELLER WAS NOTICED TO VIBRATE WITHIN THE MOTOR RECEPTACLE. THE ALARMS WERE NOT ABLE TO BE SILENCED. THE MOTOR WAS CONNECTED TO A SECOND LOOP AND A HUMMING SOUND ALONG WITH A S3 SYSTEM ALERT WERE OBSERVED. THE MOTOR WAS FORWARDED TO PPE FOR FURTHER ANALYSIS. UPON ARRIVAL AT PPE, CONTINUITY TESTING REVEALED OPEN LINES ON THE HX/HY AND SCL/SDA LINE WHICH WOULD CAUSE MOTOR ALARMS. THE MOTOR CABLE PASSED THE INSULATION TEST. THE MOTOR CABLE WAS DISSECTED AT BOTH BEND RELIEFS AND NO DAMAGE TO THE WIRES WAS OBSERVED. CONTINUITY TESTING ON EACH OF THE INDIVIDUAL FOUR WIRES REVEALED NO ISSUES. A MANUFACTURING ANALYSIS TASK WAS OPENED TO INVESTIGATE THE MOTOR CABLE WIRE FATIGUE. WHILE THE PROBLEM COULD BE TRACED DOWN TO THE SOLDER CONNECTION OF PINS 1-6, THE FINAL ROOT CAUSE REMAINS INCONCLUSIVE. THE MOST LIKELY ROOT CAUSE FOR THE LOOSE CONTACT (I.E. WIRE OR WIRE-PIN SEPARATION) IS A COMBINATION OF A HIDDEN SOLDER JOINT ISSUE (DISTURBED OR COLD JOINT) AND AN IMPROPERLY HANDLED AND/OR STORED CENTRIMAG MOTOR BY THE CUSTOMER. A SUPPLIER QUALITY ALERT WAS INITIATED TO INFORM THE SUPPLIER KUK ELECTRONICS. 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 PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. 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 ENTITLED "APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING MOTOR-RELATED ALARMS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
CHANGING THE MOTORS RESOLVED THE PROBLEM, AND THE PATIENT WAS ABLE TO CONTINUE ON SUPPORT WITH NO FURTHER EQUIPMENT ISSUES.
IMAGES WERE PROVIDED OF THE CENTRIMAG CONSOLE WHICH WAS SHOWN DISPLAYING A MOTOR ALARM (M4), A SET SPEED NOT REACHED ALARM (M5), AND A SYSTEM ALERT (S3) ALARM.
IT WAS REPORTED THE CENTRIMAG PUMP DID NOT SEAT PROPERLY IN THE MOTOR. THE MOTOR WOULD BE RETURNED FOR REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1684653 | CENTRIMAG MOTOR, US | BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE | QNR | THORATEC SWITZERLAND GMBH | 102956 | 8949508 | 07640135140078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |