CENTRIMAG BLOOD PUMP
Report
- Report Number
- 3003306248-2025-00138
- Event Type
- Death
- Date Received
- April 22, 2025
- Date of Event
- February 4, 2025
- Report Date
- December 5, 2025
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140627
- PMA / PMN Number
- K020271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORT OF AIR IN THE CIRCUIT COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REQUIRED AN EMERGENT CIRCUIT EXCHANGE TO A PRE-PRIMED BACKUP CIRCUIT WITH VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO). DURING THE EXCHANGE, THE PATIENT CODED. AFTER INITIATING SUPPORT ON THE BACKUP CIRCUIT, AIR WAS REPORTEDLY IDENTIFIED IN THE CIRCUIT THAT WAS UNABLE TO BE REMOVED WITHOUT CAUSING ADDITIONAL HARM TO THE PATIENT, AND THE PATIENT EXPIRED. IT WAS REPORTED THAT THE AIR HAD LIKELY ENTERED THE SYSTEM DURING PRIMING. IT WAS REPORTED THAT THE CENTRIMAG BLOOD PUMP WOULD NOT BE RETURNED FOR EVALUATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #2: ENSURE THAT THE PUMP AND CIRCUIT HAVE BEEN DEBUBBLED AND PRIMED PROPERLY PRIOR TO USE TO MINIMIZE THE RISK OF AIR ENTRY TO THE PATIENT. IFU WARNING #3: MASSIVE AIR ENTRY INTO THE PUMP WILL CAUSE THE PUMP TO DEPRIME AND BLOOD FLOW TO STOP. CLAMP THE OUTLET TUBING, STOP THE PUMP, AND REMOVE AIR PRIOR TO RESUMING CIRCULATION. IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU WARNING #14: DO NOT OPERATE THE PUMP WITH ITS INLET TUBING CLAMPED AS A NEGATIVE PRESSURE WILL BE GENERATED IN THE PUMP AND AIR BUBBLES MAY BE FORMED IN THE PRIMING FLUID OR BLOOD. IFU WARNING #16: AS WITH ALL CONTINUOUS FLOW PUMPS, OPERATING AT TOO HIGH A SPEED CAN RESULT IN NEGATIVE PRESSURE AT THE INLET WHICH CAN LEAD TO COLLAPSE OF THE VENTRICLE OR BLOOD VESSELS, INLET CANNULA OBSTRUCTION, INSPIRATION OF AIR, OUTGASSING, CAVITATION AND INCREASED RISK OF EMBOLISM. ALWAYS OPERATE THE SYSTEM AT THE LOWEST SPEED CONSISTENT WITH THE VOLUME OF BLOOD AVAILABLE TO BE PUMPED AND CLINICALLY ACCEPTABLE CIRCULATORY SUPPORT. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE SECTION TITLED ¿PUMP SETUP AND OPERATION¿ PROVIDES INSTRUCTIONS FOR INSERTING THE CANNULA AND DE-AIRING THE SYSTEM. THIS SECTION WARNS ¿DO NOT OVER TIGHTEN SUTURES WHEN SECURING CANNULAE TO TISSUES AND VESSELS. OVER TIGHTENED SUTURES MAY RESULT IN OBSTRUCTION AND INTERRUPTION OF BLOOD FLOW THROUGH THE CANNULAE. SUTURING USED TO SECURE CANNULA MUST BE MADE WITH SUFFICIENT TENSION TO HOLD THE CANNULA IN PLACE OVER THE FULL RANGE OF PATIENT ACTIVITY. FAILURE TO EFFECTIVELY SECURE CANNULAE IN PLACE POSES RISK OF DECANNULATION, BLEEDING, OR AIR EMBOLUS.¿ THIS SECTION ALSO WARNS ¿IF LEAKS OR OTHER ANOMALIES ARE FOUND IN THE CIRCUIT, REMOVE THE PUMP AND REPLACE WITH A NEW, STERILE PUMP, REPEATING THE ABOVE STEPS TO PRIME.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
D2B: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
CORRECTED DATA: SECTION H10: MEDWATCH NUMBER ADDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: IT WAS ULTIMATELY REPORTED THAT THE BACKUP/PRE-PRIMED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT DID NOT INCLUDE A CENTRIMAG DEVICE. NO FURTHER CENTRIMAG DEVICE ISSUES WERE REPORTED OR IDENTIFIED THROUGH THIS EVALUATION. REFER TO THE CENTRIMAG PUMP INVESTIGATION OF PUMP LOT #L08279-LA4 REGARDING THE REPORTED EVENTS, INCLUDING THE EVENTS LEADING UP TO THE CIRCUIT EXCHANGE. IT WAS ULTIMATELY REPORTED THAT THE BACKUP/PRE-PRIMED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT DID NOT INCLUDE A CENTRIMAG DEVICE. IT WAS ULTIMATELY REPORTED THAT THE BACKUP/PRE-PRIMED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT DID NOT INCLUDE A CENTRIMAG DEVICE. ALTHOUGH NO FURTHER CENTRIMAG DEVICE ISSUES WERE REPORTED, THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PATIENT WAS ON VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO). ON (B)(6) 2025 AT APPROXIMATELY 23:32, IT WAS IDENTIFIED THAT THE VENOUS CANNULA CRACKED AND DISCONNECTED FROM CIRCUIT. A CIRCUIT EXCHANGE WAS PERFORMED IN ATTEMPT TO STOP EXSANGUINOUS DRAINAGE. DURING TIME OF CIRCUIT, THE PATIENT CODED AND WAS PLACED BACK ON VV ECMO BUT BUBBLES WERE IDENTIFIED IN THE CIRCUIT WITH INABILITY TO GET OUT WITHOUT CAUSING ADDITIONAL HARM TO PATIENT. THE PATIENT PASSED AWAY AT 00:05 ON (B)(6) 2025 WHEN THE CENTRIMAG BLOOD PUMP WAS "BUMPED BY STAFF" WHICH CAUSED AIR TO GET IN THE CIRCUIT. THE PATIENT WAS NON-PULSATILE ALREADY AND THE AIR CAUSED THE PATIENT TO PASS AWAY. PER THE SITE, GIVEN THE CIRCUMSTANCES, IT WAS BELIEVED THAT THE HARDWARE WAS NOT AT FAULT AND WOULD NOT BE RETURNED. THE STAFF IN THE ROOM "KNOCKED INTO THE PUMP" ALLEGEDLY CAUSING A CRACK WHICH REQUIRED SWITCHING THE CIRCUIT DUE TO THE PATIENT EXSANGUINATING. A NEW PRE-PRIMED CIRCUIT WAS INITIATED, AND AIR WAS IDENTIFIED POST INITIATION. THE PATIENT DECEASED BECAUSE THE AIR WAS UNABLE TO BE SAFELY REMOVED. THE STAFF IN THE ROOM "KNOCKED INTO THE PUMP" ALLEGEDLY CAUSING A CRACK WHICH REQUIRED SWITCHING THE CIRCUIT DUE TO THE PATIENT EXSANGUINATING. A NEW PRE-PRIMED CIRCUIT WAS INITIATED, AND AIR WAS IDENTIFIED POST INITIATION. THE PATIENT DECEASED BECAUSE THE AIR WAS UNABLE TO BE SAFELY REMOVED. THE PUMP WAS A PRE-PRIMED CIRCUIT THAT WAS READY FOR EMERGENCIES PRIOR TO THE EVENT. PER TWO SEPARATE PHONE CALLS, AIR WAS IDENTIFIED IN THE CIRCUIT BEFORE INITIATING SUPPORT AND LIKELY ENTERED THE SYSTEM DURING PRIMING. AFTER FOLLOW-UP THE ECMO COORDINATOR COMMUNICATED "THE CHANGE OUT WAS ATTEMPTED BUT WAS UNSUCCESSFUL BECAUSE THE PATIENT [HAD PASSED AWAY]¿.
THE ECMO SPECIALIST AND REGISTERED NURSE (RN) WERE BATHING THE PATIENT, AFTER THE BATH, THE RN WALKED PAST THE MACHINE AND BUMPED IT WITH THEIR HIP. THE MACHINE THEN BEGAN ALARMING LOW FLOW AND THE ECMO SPECIALIST RESPONDED AND NOTICED EXSANGUINATION COMING FROM THE TUBING. REGARDING THE SECOND CIRCUIT THAT COULD NOT BE PLACED ON THE PATIENT, IT WAS UNABLE TO BE IDENTIFIED HOW THERE WAS AIR IN IT. IT BEGAN ALARMING WHEN THERE WERE BUBBLES AFTER PERFORMING THE CIRCUIT EXCHANGE
THE TUBING WAS IMMEDIATELY CHECKED BY THE ECMO SPECIALIST IN THE ROOM AS SOON AS IT STARTED ALARMING. PRIOR TO THIS, EACH SECTION OF THE TUBING WAS PROPERLY SECURED TO THE CENTRIMAG PUMP WITH TWO "ZIP TIES".
UPON FURTHER REVIEW, THIS PRODUCT WAS DETERMINED TO NOT BE AN ABBOTT PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1161526 | CENTRIMAG BLOOD PUMP | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | QNR | THORATEC SWITZERLAND GMBH | 102953 | 07640135140627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Death |