CENTRIMAG MOTOR, US
Report
- Report Number
- 3003306248-2024-04374
- Event Type
- Malfunction
- Date Received
- July 8, 2024
- Date of Event
- June 13, 2024
- Report Date
- September 30, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140078
- PMA / PMN Number
- K020271
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
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. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN S3: SYSTEM FAULT ALARM WAS CONFIRMED VIA THE LOG FILE THAT WAS EXTRACTED FROM THE CENTRIMAG CONSOLE (EVALUATED SEPARATELY). THE LOG FILE CAPTURED AN S3 ALARM ON 13JUN2024 WHILE THE SYSTEM WAS OPERATING AROUND THE SET SPEED. THE ALARM DID NOT PREVENT THE SYSTEM FROM OPERATING AS INTENDED AND RESOLVED ON THE SAME DAY; THE CAUSE OF THE ALARM WAS UNABLE TO BE CONCLUSIVELY DETERMINED FROM THE LOG FILE ALONE. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AND WAS FOUND TO PERFORM AS INTENDED. ATYPICAL EVENTS WERE UNABLE TO BE REPRODUCED, EVEN WHEN THE MOTOR¿S CABLE WAS MANIPULATED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. INCIDENTAL FINDINGS: KINK IN MOTOR CABLE NEAR MOTOR-SIDE BEND RELIEF. REVIEW OF THE DEVICE HISTORY RECORD FOR CENTRIMAG MOTOR, 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 "WARNINGS AND 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 12.1-"APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING S3 ALARMS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. 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 DOES NOT 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.
THE PUMPS CLOT BURDEN WAS KNOWN BY CRITICAL CARE AND CT SURGERY PROVIDERS, WITH NO CHANGES TO THE PUMP SINCE THE FLOWS DID NOT CHANGE AND FREE HEMOGLOBIN WAS STABLE AT 30. THE PATIENT HAD GONE TO THE CARDIOVASCULAR OPERATING ROOM (CVOR) FOR AN EMERGENT (NOT EMERGENT BECAUSE OF THIS ISSUE) RECONFIGURATION TO VAV ECMO. THE PATIENT PRESENTED WITH INCREASED FREE HEMOGLOBIN 120 -980 AND DECREASED RIGHT VENTRICULAR ASSIST DEVICE (RVAD) FLOW. THE PATIENTS' ROTATIONS ER MINUTE (RPMS) WERE ORDERED FOR 1900, FLOWING AROUND 1.8-2LPM. THERE WAS NO LOSS OF FLOW IN DOCUMENTATION ON (B)(6) 2024 OR SEVERAL DAYS BEFORE. THE ONSET DATE FOR ATRIAL/VENTRICULAR THROMBUS HISTORY WAS A FEW DAYS. THE FREE HEMOGLOBIN INCREASE STARTED THE DAY BEFORE THEY WENT TO THE CVOR, BUT THE FREE HEMOGLOBIN WAS APPROX. 30, EVERY DAY FOR SEVERAL DAYS. CHANGES TO THE PATIENT'S ANTICOAGULATION THAT MAY HAVE CONTRIBUTED INCLUDED SUSPECTED SEPSIS, WORSENING KIDNEY FAILURE, AND INCREASED LACTIC ACID, THE REASONS WHY THE PATIENT HAD GONE FOR RECONFIGURATION TO VAV ECMO FROM HM3 AND PROTEK+CENTRIMAG RVAD. THERE WERE NO CHANGES MADE TO THE PUMP PARAMETERS AND NO DIAGNOSTIC TESTING USED. NO COMPUTED TOMOGRAPHY SCAN IMAGES ARE AVAILABLE. IT WAS NOTED THAT THE S3 ALARM WAS NOT NOTED BY STAFF WHEN THEY LEFT THE CVOR, AND THE FLOWS ON THE LVAD WERE RUNNING AROUND 3.5LPM, BUT THE CENTRIMAG FLOW WAS 2LPM. THE PATIENT WAS SUCCESSFULLY WEANED FROM VAV ECMO AND REMAINED ON THE HM3 LVAD.
IT WAS REPORTED THAT AN S3 ALARM OCCURRED IN THE OPERATING ROOM WITH 3.5 LPM FLOW. THIS PATIENT WAS ON CENTRIMAG RIGHT VENTRICULAR ASSIST DEVICE (RVAD) AND PROTEKDUO. THE PATIENT WAS CONCURRENT ON A LEFT VENTRICULAR ASSIST DEVICE (LVAD). AFTER FURTHER INVESTIGATION IT WAS NOTED THAT THE PUMP CONTAINED LARGE AMOUNTS OF THROMBUS. THE CIRCUIT WAS EXCHANGED FOR A CARDIOHELP HLS, AND THE PATIENT WAS RE-CANNULATED FOR VENO-ARTERIAL-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VAV ECMO). IT WAS NOTED THE PATIENT HAD A HISTORY OF ATRIAL AND VENTRICULAR THROMBUS AND OBTAINING THERAPEUTIC ACTIVATED CLOTTING TIME (ACT) DURING IMPLANT. ON 14JUN2024 THE PATIENT HAD FREQUENT LOW FLOW ALARMS. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE CAPTURED LOW FLOW ALARM EVENTS ON 14JUN2024. THERE WERE ALSO SEVERAL MOMENTARY LOW FLOW EVENTS RECORDED, SOME OF WHICH WERE VERY BRIEF AND DID NOT GENERATE AN ALARM. THERE DID NOT APPEAR TO BE ANY TYPE OF EXTERNAL MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT ISSUES CAUSING THESE EVENTS.
ADDITIONAL SYMPTOMS INCLUDED FEELING WEAK, LIGHTHEADEDNESS, LOW BLOOD PRESSURE, AND CARDIOGENIC SHOCK UNTIL PLACED ON ADDITIONAL ECMO SUPPORT. ON (B)(6) 2024 THE PATIENT REMAINED ON VAV ECMO AND STILL HAD THE LARGE BILATERAL PULMONARY EMBOLI. IT WAS NOTED THAT THE PATIENTS HAD MULTIPLE PERIODS OF MCS SUPPORT DURING THIS TIME, INCLUDING RVAD, ECMO SUPPORT, AND THE HEARTMATE 3. THE PATIENT REMAINED ON VAV ECMO UNTIL IT WAS DISCONTINUED ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833422 | CENTRIMAG MOTOR, US | BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE | QNR | THORATEC SWITZERLAND GMBH | 102956 | 07640135140078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male |