CENTRIMAG BLOOD PUMP
Report
- Report Number
- 3003306248-2024-04421
- Event Type
- Injury
- Date Received
- September 9, 2024
- Date of Event
- July 8, 2024
- Report Date
- November 21, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140627
- PMA / PMN Number
- K020271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION B5: CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH THE CENTRIMAG BLOOD PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) LISTS BLEEDING, INFECTION, AND CARDIAC ARRHYTHMIAS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. THIS IFU ALSO PROVIDES THE FOLLOWING 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. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND OPERATION MANUAL 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.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
ON (B)(6) 2024, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. THE PATIENT WAS GIVEN AMIODARONE BOLUS THREE TIMES, LIDOCAINE 100 MG ONCE, MAGNESIUM 4 MG ONCE, POTASSIUM 40 MILLIEQUIVALENTS ONCE AND THE PATIENT RECEIVED CARDIOVERSION AT 100 J. AMIODARONE DRIP AND EPINEPHRINE DRIP WAS RESTARTED AT 0.08 MCG/KG/MI. THE ELECTROPHYSIOLOGIST WAS RE-CONSULTED.
THE URINALYSIS POSITIVE FOR LEUKOCYTES AND HAVING WHITE BLOOD CELLS INDICATIVE OF INFECTION WAS DONE ON (B)(6) 2024. THE ARRHYTHMIA RESOLVED ON (B)(6) 2024.
IT WAS REPORTED THAT THE PATIENT HAD POST OPERATIVE BLEEDING REQUIRING THEIR CHEST TO BE KEPT OPEN AFTER THE PROCEDURE. 1 UNIT OF PACKED RED BLOOD CELLS (PRBCS) AND 3 PLATELETS WERE USED. LATER 2 MORE UNITS OF PRBCS WERE USED IN THE INTENSIVE CARE UNIT (ICU) FROM (B)(6) 2024 TO (B)(6) 2024. ON (B)(6) 2024 A WASHOUT PROCEDURE WAS PERFORMED AND THE CHEST REMAINED OPEN UNTIL (B)(6) 2024 WHEN IT WAS CLOSED. THE BLEEDING RESOLVED WITHOUT SEQUELAE. ON (B)(6) 2024 THE PATIENT WENT INTO ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RESPONSE (RVR) NOTED. THE PATIENT WAS GIVEN AMIODARONE BOLUS TWICE AND STARTED ON AMIODARONE DRIP AT 1 MG/MIN. ON (B)(6) 2024 THE AMIODARONE DRIP WAS DECREASED TO 0.5 MG/MIN. ON (B)(6) 2024 THE AMIODARONE TRANSITIONED TO 400 MG TWICE A DAY ORALLY. ON (B)(6) 2024 HEMATURIA WAS NOTED. THE HEPARIN DRIP WAS CHANGED TO BIVALIRUDIN. THE ACETYLSALICYLIC ACID (ASA) WAS STOPPED AS PATIENT HAD NO HISTORY OF ISCHEMIC DISEASE. THE BLEEDING QUICKLY RESOLVED ON (B)(6) 2024 AS THERE WERE NO SIGNS OF BLEEDING NOTED. ON (B)(6) 2024 URINALYSIS WAS POSITIVE FOR LEUKOCYTES AND WHITE BLOOD CELLS, INDICATIVE OF INFECTION. CULTURES WERE PENDING. THE PATIENT WAS THEN STARTED ON CEFTAZIDIME 2 MG INTRAVENOUS (IV) EVERY 8 HOURS. CULTURES RESULTS FOUND KLEBSIELLA PNEUMONIAE IN THE URINE. THE PATIENT WAS STARTED ON MEROPENEM 1000 MG INTRAVENOUS EVERY 8 HOURS. ON (B)(6) 2024 THE MEROPENEM WAS COMPLETED AND THE INFECTION RESOLVED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537765 | 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 | 48 YR | Male | Required Intervention| H |