BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 20208737 · Received September 12, 2024

    Report

    Report Number
    3003306248-2024-04422
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 22, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Removal / Correction Number
    FA-Q325-HF-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED CENTRIMAG BLOOD PUMP CONFIRMED DAMAGE CONSISTENT WITH AN IMPROPER FIT OF THE PUMP INTO THE CENTRIMAG MOTOR. ALTHOUGH A SPECIFIC CAUSE FOR THE IMPROPER FIT OF THE PUMP INTO THE CENTRIMAG MOTOR COULD NOT BE CONCLUSIVELY DETERMINE THROUGH THIS EVALUATION, THE PUMP HOUSING WAS FOUND TO BE OUT OF SPECIFICATION WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE. THE CENTRIMAG BLOOD PUMP, LOT 10234424, WAS RETURNED WITH A SHORT PIECE OF TUBING CONNECTED TO THE OUTLET PORT. THE PUMP¿S INLET AND OUTLET PORTS APPEARED UNREMARKABLE. EXAMINATION OF THE PUMP HOUSING FOUND SOME SCRATCH MARKS ON THE EXTERIOR OF THE BOTTOM PUMP HOUSING CONSISTENT WITH ROTATING THE PUMP IN THE MOTOR. IMPRESSION MARKS WERE NOTED NEXT THE FOUR GROOVES ON THE PERIPHERY OF THE BLOOD PUMP HOUSING. EXAMINATION OF THE INTERIOR OF THE PUMP HOUSING FOUND CONCENTRIC SCRATCHES/GOUGES IN THE CLEAR HOUSING BENEATH THE IMPELLER BLADES. THE IMPELLER BLADES ALSO HAD EVIDENCE OF MATERIAL ABRASION ALONG THE BOTTOM/BACK SIDES OF THE BLADES. THE ROTOR BASE SHOWED NO EVIDENCE OF ABRASION OR OTHER DAMAGE. THE ROTOR WELL REVEALED NO EVIDENCE OF ABNORMAL SCRATCHING OR OTHER DAMAGE. THERE WAS NO EVIDENCE OF SEPARATION OR SLIPPAGE BETWEEN THE ROTOR MAGNET AND ROTOR BODY. THE RETURNED PUMP WAS FORWARDED TO THE ABBOTT ZURICH RESEARCH AND DEVELOPMENT (R&D) TEAM FOR INVESTIGATION. THE R&D TEAM DETERMINED THAT THE FIT RELEVANT PUMP DIMENSIONS WERE OUT OF SPECIFICATION, SCRATCH/ABRASION MARKS INDICATED A MIS-FIT BETWEEN PUMP THICKNESS AND MOTOR GAP WIDTH, AND THE NON-FIT WAS CONFIRMED IN A FIT TEST WITH AT LEAST ONE TEST MOTOR. THE POTENTIAL CONTRIBUTION OF THE INVOLVED MOTOR TO THE FIT ISSUE REMAINS INCONCLUSIVE SINCE THE UNIT WAS NOT SENT BACK BY THE CUSTOMER. THE DAMAGES ON THE OUTSIDE OF THE PUMP REVEALED THAT THE PUMP WAS CORRECTLY INSERTED AT LEAST ONCE AND IN TWO INSTANCES THE LOCKING SCREW WAS TIGHTENED WITHOUT PRIOR ROTATION OF THE PUMP. THUS, THE PUMP HOUSING WAS TILTED. IF THE USER WAS NOT ABLE OR FORGOT TO ROTATE THE PUMP REMAINS INCONCLUSIVE. THE DAMAGE OF THE IMPELLER DUE TO CONTACT WITH THE PUMP HOUSING COULD BE CONFIRMED. MOREOVER, THE DAMAGES ON THE OUTSIDE AND ON THE INSIDE REVEALED THAT CONTACT WAS ENABLED BY A TILTED PUMP HOUSING. A CORRECTIVE ACTION AND PREVENTATIVE ACTION (CAPA) INVESTIGATION HAS ALSO BEEN OPENED TO ADDRESS DEFORMED CENTRIMAG PUMP HOUSINGS WITH DIMENSIONS OUT OF SPECIFICATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR LOT NUMBER 10234424 (L08210- LA7) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE AND PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #8: ENSURE THE PUMP IS PROPERLY LOCKED INTO THE MOTOR PER THE INSTRUCTIONS FOR USE SUPPLIED WITH THE MOTOR. 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 HOW TO MOUNT THE BLOOD PUMP ON THE MOTOR. THE FOLLOWING INSTRUCTIONS ARE PROVIDED: TO MOUNT THE PUMP ON THE MOTOR, REMOVE THE PUMP FROM THE INNER TRAY AND INSERT THE PUMP INTO THE MOTOR RECEPTACLE. PLACE THE BOTTOM OF THE PUMP INTO THE MOTOR RECEPTACLE WITH THE OUTLET PORT POSITIONED IN THE LARGE GROOVE. MATCH THE GROOVES ON THE PERIPHERY OF THE PUMP WITH THE FITTINGS ON THE MOTOR RECEPTACLE. ROTATE THE PUMP COUNTERCLOCKWISE UNTIL THE PUMP LOCKS SECURELY INTO PLACE. THREAD THE RETAINING SCREW CLOCKWISE TO SECURE IN PLACE. THE PUMP MUST BE FULLY SEATED INTO THE RECEPTACLE TO FUNCTION PROPERLY. THE SECTION TITLED ¿EMERGENCY BACKUP EQUIPMENT¿ STATES THAT A BACKUP STERILE PUMP AND SUPPLIES TO PRIME MUST BE AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PERFUSIONIST PRIMED THE CENTRIMAG SYSTEM AND NOTED DAMAGE FROM THE IMPELLER. NO PATIENT WAS INVOLVED. THE HOSPITAL REQUESTED A NEW PUMP HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106391 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90010 10234424 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown