BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM

    MDR report key: 13604473 · Received February 25, 2022

    Report

    Report Number
    3004582654-2022-00014
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N: (B)(4), ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2021 UNTIL (B)(6) 2022 (221 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N: (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION COULD BE DETECTED BETWEEN THE MEMBRANE LAYERS. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT DID NOT REACH ITS REQUIRED FUNCTIONAL SPECIFICATION, CONFIRMING THE CUSTOMER'S COMPLAINT. FOR FURTHER ANALYSIS, THE PUMP WAS DISASSEMBLED, AND THE MEMBRANE LAYERS WERE INDIVIDUALLY EXAMINED. A LEAKAGE WAS DETECTED IN THE AIR-SIDE LAYER ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. FURTHERMORE, GRAPHITE ABRASION WAS FOUND BETWEEN THE MEMBRANES. THE MIDDLE LAYER AND THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. THE THICKNESS OF THE DEFECTIVE MEMBRANE LAYER, AND THE ONE ADJACENT WAS RE-MEASURED AT DEFINED POINTS. THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL DEFINED POINTS AND IN THE AREA AROUND THE LEAKAGE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF THE REMEASUREMENT. THE CAUSE OF THE LEAKAGE IN THE AIR-SIDE LAYER WAS MOST LIKELY A GRAPHITE ABRASION BETWEEN THE MEMBRANE LAYERS. THIS CAUSED INCREASED FRICTION AT SOME POINTS, WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN BETWEEN THE MEMBRANE LAYERS AND FORMED AN AIR CUSHION, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE SITE ON 13-02-2022 TO REQUEST REPLACEMENT DISPOSABLES FOR A PUMP CHANGE THAT OCCURRED ON (B)(6) 2022. THE SITE REPORTED THAT THE PUMP WAS EXCHANGED DUE TO CONCERN FOR INABILITY TO FULLY EJECT. THE PUMP EXCHANGE WAS WITHOUT UNTOWARD EFFECT TO THE PATIENT. WHEN THE INITIAL CONTACT WAS MADE NO FURTHER DETAILS WERE AVAILABLE. BERLIN HEART INC. CONTACTED THE SITE ON 14-02-2022 TO GATHER MORE INFORMATION ABOUT THE EVENT. THE SITE THEN REPORTED THAT THE POOR EJECTION WAS NOTED DURING A ROUTINE VISUAL INSPECTION OF THE BLOOD PUMP. THE PATIENT WAS HEMODYNAMICALLY STABLE, ALERT AND PLAYFUL. THE IKUS DRIVING UNIT HAD HAD NO ALARMS. THE INTENSIVIST IN THE ICU INCREASED THE SYSTOLIC PARAMETER WITHOUT ANY IMPROVEMENT IN EJECTION. THE SITE THEN DECIDED TO CHANGE THE BLOOD PUMP. THE SURGICAL TEAM CHANGED THE PUMP AT THE PATIENT'S BEDSIDE WITHOUT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229756 BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female