BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

    MDR report key: 13157346 · Received January 4, 2022

    Report

    Report Number
    3004582654-2022-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 22, 2021
    Report Date
    January 4, 2022
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, (B)(4) WAS IN USE BY THE PATIENT FROM (B)(6) 2021 UNTIL (B)(6) 2021 (38 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE BLOOD PUMP IS DESIGNED WITH A TRIPLE LAYER MEMBRANE SEPARATING THE AIR CHAMBER FROM BLOOD CHAMBER FOR SAFETY REASONS. THE ENTIRE MEMBRANE CONSISTS OF AN AIR-SIDE LAYER, A MIDDLE LAYER AND A BLOOD-SIDE LAYER. IN CASE OF DISRUPTION IN ONE OF THE THREE LAYERS, THERE ARE TWO MORE LAYERS THAT WILL MAINTAIN THE INTEGRITY OF THE AIR AND BLOOD CHAMBERS. 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 NO ABNORMALITY COULD BE DETECTED. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE. THE PUMP MET ITS REQUIRED FUNCTIONAL SPECIFICATION. DURING TESTING, PUMPING NOISES OF THE BLOOD PUMP CAN BE HEARD. HOWEVER, IN THIS CASE THESE NOISES ARE NOT UNUSUAL COMPARED TO OTHER BLOOD PUMPS. FOR FURTHER INVESTIGATION, THE BLOOD PUMP WAS DISASSEMBLED, AND THE MEMBRANE LAYERS WERE EXAMINED INDIVIDUALLY. ALL THREE LAYERS OF THE MEMBRANE ARE INTACT. NO UNUSUAL AMOUNT OF LOOSE GRAPHITE WAS SEEN AND SPREAD EVENLY ON ALL LAYERS. NEITHER A DEFECT NOR A MALFUNCTION COULD BE DETERMINED. THE BLOOD PUMP MET ITS SPECIFICATION. THE PUMPING NOISE OF THE PUMP IN QUESTION IS NOT UNUSUAL COMPARED TO OPERATING NOISE OF OTHER BLOOD PUMPS.

    Description of Event or Problem · 0

    BERLIN HEART WAS CONTACTED BY THE CLINIC TO REPORT A SUSPECTED MEMBRANE DEFECT IN THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE AFFECTED BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192952 BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001X02 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Male