BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM

    MDR report key: 16869254 · Received May 4, 2023

    Report

    Report Number
    3004582654-2023-00016
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP (SN (B)(6) WAS RETURNED TO BERLIN HEART GMBH ON (B)(6) 2023 FOR EVALUATION. AFTER A VISUAL INSPECTION, NO ABNORMALITIES WERE FOUND, AND THE TRIPLE LAYER MEMBRANE WAS IN THE CORRECT POSITION WITHOUT ANY PILLOW FORMATION. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AND MET ALL SPECIFICATIONS WITH COMPLETE FILLING AND EMPTYING. FOR FURTHER EVALUATION, THE PUMP WAS DISASSEMBLED, AND EACH INDIVIDUAL MEMBRANE LAYER WAS EXAMINED. ALL THREE LAYERS WERE INTACT, THE GRAPHITE DISTRIBUTION WAS UNIFORM WITHOUT GAPS, AND THE STABILIZING RING WAS DEFECT-FREE. AFTER THOROUGH ANALYSIS, NO DEFECTS OR MALFUNCTIONS WERE FOUND, AND THE BLOOD PUMP MET ALL SPECIFICATIONS. THE FILLING AND EMPTYING PROBLEMS DESCRIBED BY THE CLINIC COULD NOT BE ATTRIBUTED TO ANY DEFECT OF THE BLOOD PUMP.

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, (B)(6), WAS IN USE ON THE PATIENT FROM FOR(B)(6) 2023 TO (B)(6) 2023 ( 87 DAYS) WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N 2230145. THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. CARE WAS WITHDRAWN FROM THE PATIENT ON(B)(6) 2023. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    THE SITE CONTACTED BHI TO REPORT THAT CARE WAS WITHDRAWN FROM THE PATIENT AND THE PATIENT EXPIRED. THE DECISION TO WITHDRAW CARE WAS BASED ON WORSENING MULTISYSTEM ORGAN FAILURE AND THE PATIENT'S POOR PROGNOSIS. PRIOR TO WITHDRAWING CARE, THE SITE REPORTED THAT THE BLOOD PUMP WAS NOT FILLING COMPLETELY AND REQUIRED A "HIGH" SYSTOLIC PRESSURE TO COMPLETELY EJECT THE PUMP. THE SITE INFORMED OUR CLINICAL AFFAIRS TEAM THAT THE PATIENT HAD BECOME SEPTIC AND THAT THE PATIENT LIKELY HAD AN OBSTRUCTION IN THE INFLOW CANNULA, HOWEVER THERE WERE NO CLOTS VISIBLE IN THE PUMP. THE SITE REPORTED IN AN EMAIL THAT WHEN THE PUMP WAS NOT FILLING COMPLETELY, THEY SWITCHED TO THE HAND PUMP "TO RULE OUT IKUS MALFUNCTION" AND THE PUMP WAS STILL NOT FILLING COMPLETELY BUT WAS EJECTING COMPLETELY. ONCE IT WAS DETERMINED THAT THE IKUS WAS WORKING PROPERLY, AND THAT THE PUMP WAS NOT FILLING, BUT WAS EJECTING WITH THE HAND PUMP, CARE WAS WITHDRAWN FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811924 BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male