CENTRIMAG BLOOD PUMP
Report
- Report Number
- 3003306248-2023-01934
- Event Type
- Death
- Date Received
- May 17, 2023
- Date of Event
- April 15, 2023
- Report Date
- May 22, 2024
- Manufacturer
- THORATEC SWITZERLAND GMBH
- Product Code
- QNR
- UDI-DI
- 07640135140627
- PMA / PMN Number
- K020271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: EXAMINATION OF THE PUMP HOUSING REVEALED SCRATCH MARKS ON THE TOP HOUSING DIRECTLY ABOVE THE ROTOR BLADES AND WITHIN IN THE ROTOR WELL. MICROSCOPIC EXAMINATION OF THE IMPELLER PORTION OF THE PUMP ROTOR REVEALED EVIDENCE OF ABRASION AND DAMAGE TO THE ROTOR BLADES AND BODY OF THE ROTOR. THE MARKS ON THE PUMP HOUSING AND THE DAMAGE TO THE ROTOR APPEARED TO BE A RESULT OF ABRASION OF THE ROTOR BODY WITH THE PUMP HOUSING DURING ROTOR ROTATION. A DROP OF CURED GLUE WAS OBSERVED ON THE ROTOR BOTTOM. THE EVALUATION OF THE RETURNED CENTRIMAG BLOOD PUMP, LOT NUMBER L06971-LA3, REVEALED A SMALL THROMBUS FORMATION ON THE ROTOR BOTTOM. IN ADDITION, EXAMINATION OF THE PUMP ALSO REVEALED A DROP OF CURED GLUE ON THE ROTOR, SCRATCH MARKS ON THE PUMP HOUSING, AND EVIDENCE OF ABRASION AND DAMAGE TO THE ROTOR. A DIRECT CORRELATION BETWEEN THESE FINDINGS AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE CENTRIMAG BLOOD PUMP, LOT NUMBER L06971-LA3, WAS RETURNED WITHOUT TUBING CONNECTED TO THE INLET AND OUTLET PORTS. VISUAL INSPECTION OF THE PUMP HOUSING REVEALED SCRATCH MARKS ON THE TOP HOUSING DIRECTLY ABOVE THE ROTOR BLADES AND WITHIN IN THE ROTOR WELL. MICROSCOPIC INVESTIGATION REVEALED THE SCRATCH MARKS WERE ON THE INTERNAL PUMP HOUSING AND APPEARED TO BE CIRCUMFERENTIAL ON THE TOP AND BOTTOM HOUSING. MICROSCOPIC EXAMINATION OF THE IMPELLER PORTION OF THE PUMP ROTOR REVEALED EVIDENCE OF ABRASION AND DAMAGE TO THE ROTOR BLADES AND BODY OF THE ROTOR. THE MARKS ON THE PUMP HOUSING AND THE DAMAGE TO THE ROTOR APPEARED TO BE A RESULT OF ABRASION OF THE ROTOR BODY WITH THE PUMP HOUSING DURING ROTOR ROTATION. NO IMPRESSIONS WERE OBSERVED NEXT TO THE FOUR GROOVES ON THE PERIPHERY OF THE BLOOD PUMP TO SUGGEST THAT THE PUMP WAS INCORRECTLY INSERTED INTO THE MOTOR AT THE TIME OF THE EVENT. EXAMINATION OF THE ROTOR BOTTOM REVEALED A SMALL, DARK RED DEPOSITION ADHERED TO THE OUTSIDE EDGE OF THE ROTOR BOTTOM. FOLLOWING CLEANING, MICROSCOPIC EXAMINATION OF THE ROTOR BASE REVEALED A DROP OF CURED GLUE WHERE THE DEPOSITION HAD BEEN LOCATED. THE EVALUATION COULD NOT DETERMINE A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE OBSERVED DEPOSITION OR A DURATION OF TIME FOR WHICH IT WAS PRESENT IN THE DEVICE. A DIRECT CORRELATION BETWEEN THE OBSERVED DEPOSITION, THE DROP OF CURED GLUE, AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. FOLLOWING CLEANING, THE BLOOD PUMP WAS FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP WITH A TEST MOTOR AND EQUIPMENT. THE BLOOD PUMP FUNCTIONED AS INTENDED IN ACCORDANCE WITH MANUFACTURING SPECIFICATION. ADDITIONAL INFORMATION STATED THERE WERE NO ABNORMAL SOUNDS OBSERVED DURING PUMP SUPPORT; HOWEVER, THE ACCOUNT CONFIRMED THROMBUS WAS VISUALIZED IN THE PUMP. IT WAS ALSO REPORTED THE MOTOR AND CONSOLE IN USE DURING THE EVENT ARE NOT AVAILABLE FOR EVALUATION. THE RETURNED PUMP WAS FORWARDED TO ABBOTT¿S ZURICH FACILITY FOR MANUFACTURING ANALYSIS TO INVESTIGATE THE DROP OF CURED GLUE ON THE ROTOR BOTTOM. THE ROOT CAUSE FOR THE PRESENCE OF THIS GLUE WAS DETERMINED TO BE RELATED TO THE VISUAL INSPECTION OF THE IMPELLER ASSEMBLY NOT BEING PERFORMED CORRECTLY AT THE SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS INITIATED AND SENT TO THE SUPPLIER. THE RETURNED PUMP WAS ALSO SENT TO ABBOTT¿S RESEARCH AND DEVELOPMENT TEAM IN ZURICH TO INVESTIGATE THE SCRATCH MARKS AND ABRASION OBSERVED ON THE PUMP HOUSING AND ROTOR. THE EXAMINATION OF THE SURFACE OF THE IMPELLER AS WELL AS THE INNER SURFACE OF THE PUMP HOUSING CONFIRMED THAT CONTACT BETWEEN IMPELLER AND HOUSING OCCURRED DURING OPERATION OF THE PUMP. CONTACT BETWEEN THE ROTOR AND HOUSING WAS ESTABLISHED AT FOUR DIFFERENT LOCATIONS. CONTACT AT ONE LOCATION, BETWEEN THE ROTOR BOTTOM AND HOUSING BOTTOM, WAS ONLY POSSIBLE DUE TO THE PRESENCE OF A DROP OF GLUE ON THE ROTOR BOTTOM. THE INVESTIGATION CONFIRMED THAT THE CONTACT BETWEEN THE ROTOR AND THE HOUSING IN THE OTHER 3 LOCATIONS WAS DUE TO THE BEARING SYSTEM NOT CENTERING AND HOLDING THE ROTOR IN PLACE. THIS CAN OCCUR DUE TO A VARIETY OF FACTORS, AND THE ROOT CAUSE FOR WHY THE BEARING SYSTEM WAS NOT ABLE TO HOLD THE ROTOR IN THE CENTER COULD NOT CONCLUSIVELY BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CENTRIMAG BLOOD PUMP, LOT L06971-LA3 REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE OUS (OUTSIDE OF UNITED STATES) CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. A) IS CURRENTLY AVAILABLE AND PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #9: POSSIBLE SIDE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, HEMOLYSIS, END ORGAN DYSFUNCTION, BLEEDING, AND EMBOLIC PHENOMENA. THESE ARE POTENTIAL SIDE EFFECTS WITH ALL MECHANICAL CIRCULATORY SUPPORT SYSTEMS. IFU WARNING #15: 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 #17: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #10: MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. IFU CAUTION #14: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE SECTION TITLED ¿EMERGENCY BACKUP EQUIPMENT¿ STATES THAT A BACKUP STERILE PUMP AND SUPPLIES TO PRIME MUST BE AVAILABLE. 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 COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS INITIATED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT REQUIRED EXPLORATION DUE TO HIGH DRAIN OUTPUT. CLOTS WERE FOUND IN PERICARDIUM. ON (B)(6) 2023, THE PATIENT WAS WEANED FORM VENTILATOR. THEIR MEAN ARTERIAL PRESSURE (MAP) SHOWED A DOWNWARD TREND AND THE PATIENT DEVELOPED OLIGURIA. THEIR URINE WAS SUGGESTIVE OF HEMOLYSIS. THE PATIENT WAS GIVEN IV FLUIDS AND THEIR VASOPRESSOR SUPPORT WAS INCREASED. THEY WERE ALSO SUPPORTED WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND CYTOSORB. ANTIBIOTICS WERE ESCALATED. ON (B)(6) 2023, CRRT & VASOPRESSORS WERE CONTINUED. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED THAT REVEALED A DILATED LEFT VENTRICLE AND THE APICAL CANNULA WAS ABUTTING AGAINST THE POSTEROLATERAL PAPILLARY MUSCLE. THE PATIENT'S RIGHT VENTRICLE FUNCTION AND SIZE WAS NORMAL. THEIR INFERIOR VENA CAVA (IVC) WAS 14 MM WITH POOR COLLAPSE. NO PERICARDIAL EFFUSION WAS NOTED. THE HEMOLYSIS WAS ONGOING WHICH WAS SUSPECTED TO BE DUE TO MECHANICAL CAUSES DUE TO THE APICAL CANNULA. THE PATIENT WAS ELECTIVELY INTUBATED IN THE ICU AND WAS TAKEN UP FOR RE-EXPLORATION IN THE OR TO RE-ADJUST THE LEFT VENTRICULAR APICAL CANNULA VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A NEW APICAL CANNULA WAS INSERTED. DESPITE FOUR TRIALS OF WEANING FROM CARDIOPULMONARY BYPASS (CPB) TO THE LVAD WERE FAILED. IT WAS DECIDED TO INSTITUTE A TEMPORARY RVAD. THE PATIENT WAS SUCCESSFULLY WEANED FROM CPB AND HEMODYNAMICS WERE MAINTAINED BY THE BIVAD. THE CHEST WAS KEPT OPEN WITH PERICARDIAL PACKING AND STERILE DRESSINGS. THE PATIENT WAS MOVED TO THE ICU FOR FURTHER MANAGEMENT. IN THE ICU BLOOD TRANSFUSIONS WERE GIVEN AS PER THROMBOELASTOGRAPHY (TEG). ON (B)(6) 2023, THE PATIENT HAD HIGH DRAIN OUTPUTS OF AROUND 1000 ML FOR WHICH TWO PACKED CELL VOLUME (PCV) OF BLOOD, ONE SINGLE DONOR PLATELET (SDP) UNIT, AND FOUR FRESH FROZEN PLASMA (FFP) WERE TRANSFUSED EARLY IN THE MORNING. SEDATION AND VENTILATION WAS CONTINUED. TEG WAS SENT AFTER WHICH 10 CRYOPRECIPITATE AND ONE BLOOD UNIT WAS TRANSFUSED. FOR THE ONGOING HEMOLYSIS, STEROIDS WERE CONTINUED AND AN SOS BLOOD TRANSFUSION WAS PLANNED FOR A HEMOGLOBIN LESS THAN 10. CRRT WAS CONTINUED DUE TO FLUCTUATIONS IN RVAD FLOWS, PERICARDIAL EXPLORATION, AND CHANGE OF DRESSING WAS DONE IN THE ICU. DESPITE CONTINUOUS BIVAD SUPPORT, CRRT, MECHANICAL VENTILATION, VASOPRESSORS, AND APPROPRIATE BLOOD PRODUCT TRANSFUSIONS, THE PATIENT HAD PERSISTENT HYPOTENSION, ACIDOSIS, AND GENERALIZED OOZING FROM THE SURGICAL SITE. A GUARDED PROGNOSIS AND POOR OUTCOMES WERE EXPLAINED TO THE FAMILY. THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA). A CODE BLUE WAS RAISED. THE PATIENT WAS RESUSCITATED ACCORDINGLY TO THE ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL. DESPITE ALL THE MEASURES, THE PATIENT COULD NOT BE REVIVED AND THEY WERE DECLARED DEAD ON (B)(6) 2023. THE CAUSE OF DEATH WAS DETERMINED TO BE DUE TO CARDIOGENIC SHOCK, STATUS POST BIVAD, ACUTE HEMOLYSIS, REFRACTORY VENTRICULAR TACHYCARDIA, AND ISCHEMIC CARDIOMYOPATHY. RVAD MFR#: 3003306248-2023-01946.
IT WAS REPORTED THAT THE PATIENT WITH CARDIOGENIC SHOCK WAS PLACED ON A CENTRIMAG FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD). HEMOLYSIS WAS NOTED AFTER A FEW HOURS OF SUPPORT. A FEW HOURS LATER, THE PATIENT REQUIRED CENTRIMAG RIGHT VENTRICULAR ASSIST DEVICE (RVAD). THE PATIENT WAS TREATED WITH BLOOD AND BLOOD PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2126527 | CENTRIMAG BLOOD PUMP | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | QNR | THORATEC SWITZERLAND GMBH | 102953 | L06971 LA3 | 07640135140627 |
| 830603 | CENTRIMAG BLOOD PUMP | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | QNR | THORATEC SWITZERLAND GMBH | 102953 | L06971 LA3 | 07640135140627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death| H| R |