CENTRIMAG BLOOD PUMP
Report
- Report Number
- 3003306248-2024-04375
- Event Type
- Injury
- Date Received
- July 8, 2024
- Date of Event
- June 13, 2024
- Report Date
- September 23, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140627
- PMA / PMN Number
- K020271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
SECTION D4: DEVICE LOT NUMBER WAS NOT PROVIDED, AND 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.
NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: PUMP THROMBUS WAS UNABLE TO BE CONFIRMED AS NO IMAGES OR PRODUCT WERE SUBMITTED FOR EVALUATION. A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION WITH THE CENTRIMAG BLOOD PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RETRIEVED CENTRIMAG CONSOLE LOG FILES CONTAINED DATA FROM (B)(6) 2024. THE PUMP SPEED WAS SET TO 1900 REVOLUTIONS PER MINUTE (RPM) FOR APPROXIMATELY 20 HOURS ON (B)(6) 2024, PER THE RECORDED TIMESTAMPS. DURING THIS TIME, FLOW TYPICALLY RANGED FROM 1.8-2.2 LPM. AN S3 SYSTEM ALERT WAS CAPTURED ON 18:30:22 ON (B)(6) 2024 THAT RESOLVED AFTER APPROXIMATELY 40 MINUTES; REFER TO THE MOTOR AND CONSOLE INVESTIGATIONS REGARDING THIS FINDING. THERE WERE NO OTHER NOTABLE ALARMS CAPTURED. THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS VENOUS THROMBOEMBOLISM, ARTERIAL NON-CNS (NON-CENTRAL NERVOUS SYSTEM) THROMBOEMBOLISM, INFECTION, AND RENAL FAILURE/DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP. THIS DOCUMENT STATES THAT IT IS INTENDED THAT SYSTEMIC ANTICOAGULATION BE UTILIZED WHILE THIS DEVICE IS IN USE AND ANTICOAGULATION LEVELS SHOULD BE DETERMINED BY THE PHYSICIAN BASED ON RISKS AND BENEFITS TO THE PATIENT. THE IFU ADDITIONALLY CAUTIONS THE USER TO MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. ALWAYS HAVE A BACKUP CENTRIMAG BLOOD PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR CHANGE OUT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE CENTRIMAG BLOOD PUMP REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE US (UNITED STATES) CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS VENOUS THROMBOEMBOLISM, ARTERIAL NON-CNS (NON-CENTRAL NERVOUS SYSTEM) THROMBOEMBOLISM, INFECTION, AND RENAL FAILURE/DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP. THE IFU CONTAINS THE FOLLOWING ADDITIONAL WARNINGS AND CAUTIONS: IFU WARNING #7: IT IS INTENDED THAT SYSTEMIC ANTICOAGULATION BE UTILIZED WHILE THIS DEVICE IS IN USE. ANTICOAGULATION LEVELS SHOULD BE DETERMINED BY THE PHYSICIAN BASED ON RISKS AND BENEFITS TO THE PATIENT. IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU WARNING #13: THE PUMP MUST BE HANDLED IN AN ASEPTIC MANNER UNTIL PRIMED AND CONNECTED TO A CLOSED TUBING CIRCUIT. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #9: MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
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 (B)(6)2024 THE PATIENT HAD FREQUENT LOW FLOW ALARMS. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE CAPTURED LOW FLOW ALARM EVENTS ON (B)(6) 2024. 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.
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 13JUN2024 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.
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 |
|---|---|---|---|---|---|---|---|
| 142539 | CENTRIMAG BLOOD PUMP | BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE | QNR | THORATEC SWITZERLAND GMBH | 102953 | 07640135140627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention |