BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM

    MDR report key: 10542886 · Received September 16, 2020

    Report

    Report Number
    3004582654-2020-00035
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6), WAS IN USE BY THE PATIENT FROM (B)(6) 2020 (196 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP COULD NOT IDENTIFY ANY DEFECT. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT MET ITS REQUIRED PUMPING SPECIFICATION. DURING THE PERFORMANCE TEST, NO UNUSUAL BEHAVIOR OF THE VALVES COULD BE DETECTED. THE PUMP WAS SENT TO AN EXTERNAL LABORATORY FOR A CT-SCAN. IN THE SCAN, NO PUMP DEFECT WAS FOUND. TO FURTHER ANALYZE THE VALVES, THE THICKNESS OF THE VALVE MATERIAL WAS SCANNED. THERE WERE NO ABNORMALITIES FOUND IN THE THICKNESS DISTRIBUTION OF THE VALVE MATERIAL. NO DEFECT COULD BE DETECTED. AFTER THOROUGH ANALYSIS, THERE IS NO INDICATION, THAT THE PUMP OR VALVES CONTRIBUTED TO THE LARGELY UNLOADED LEFT VENTRICLE, WHICH THE CLINIC REPORTED. IN B5, THE CORRECT SENTENCE IS THAT THE CLINIC OBSERVED A LARGELY UNLOADED LEFT VENTRICLE, NOT AN UNLOADED PUMP.

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2020 TO (B)(6) 2020 DAYS. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (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 TRIPLE LAYERS, THERE ARE TWO MORE LAYERS THAT WILL MAINTAIN THE INTEGRITY OF THE AIR AND BLOOD CHAMBERS. THE AFFECTED BLOOD PUMP HAS NOT BEEN RETURNED TO US YET. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 1

    BERLIN HEART WAS CONTACTED BY THE CLINIC TO REPORT A SUSPECTED DEFECT IN A VALVE OF THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC REPORTED THAT THEY OBSERVED A LARGELY UNLOADED LEFT PUMP. 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
    1005333 BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR