BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PUMP PU VALVES 10 ML, IN/OUT 6 MM

    MDR report key: 10649407 · Received October 8, 2020

    Report

    Report Number
    3004582654-2020-00041
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, RED-BROWN DEPOSITS COULD BE DETECTED IN THE MEMBRANE INTERSTICES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A DEFECT IN THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE WAS DETECTED. THE DEFECT WAS LOCATED DIRECTLY OPPOSITE THE DE-AIRING PORT AND CORRESPONDED IN APPEARANCE TO THE SHAPE AND SIZE OF THE DE-AIRING CANNULA'S TIP. BASED ON THE ENTRY AND EXIT POINTS IN THE DE-AIRING PORT, THE DIRECTION OF THE ENTRY CANAL FOR PRIMING COULD BE RECONSTRUCTED AND COINCIDED WITH THE DAMAGED LOCATION IN THE BLOOD-SIDE LAYER. BETWEEN THE BLOOD-SIDE LAYER AND THE MIDDLE LAYER DRIED BLOOD WAS FOUND. THE AIR-SIDE LAYER AND THE MIDDLE LAYER WERE FOUND TO BE INTACT. THE CAUSE OF THE DEFECT IS MOST LIKELY AN ACCIDENTAL PUNCTURING OF THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE BY THE DE-AIRING CANNULA DURING PRIMING OF THE BLOOD PUMP. THIS LED TO A LEAKAGE IN THE BLOOD-SIDE LAYER.

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2020. ON (B)(6) 2020, BERLIN HEART REGULATORY AFFAIRS RECEIVED A MEDWATCH FORM 3500A (REPORT # 0533050000-2020-8085) REPORTING THAT AN INCIDENT OCCURRED IN JUNE 2020 INVOLVING BLOOD PUMP 1920030 (P10P-001). INITIAL INVESTIGATION BY BERLIN HEART COULD NOT FIND ANY IMPLANT RECORDS REPORTED TO BERLIN HEART WITH THE SERIAL NUMBER LISTED ON THE MEDWATCH REPORT, THEREFORE, BERLIN HEART ASSUMED THIS WAS A MISTAKE ON PART OF THE SITE, AND WAS RELATED TO ANOTHER SIMILAR COMPLAINT THAT HAD OCCURRED IN LATE MAY (C-1429; MDR 3004582654-2020-00025). THERE WERE NO COMPLAINTS REPORTED DURING THE MONTH OF JUNE FROM THIS SITE. BERLIN HEART CONTACTED THE SITE MULTIPLE TIMES TO OBTAIN INFORMATION REGARDING THE MEDWATCH REPORT. THE SITE DID NOT REPORT BACK TO BERLIN HEART UNTIL 2020-09-21. THE SITE CONFIRMED THE USE OF THE BLOOD PUMP REFERENCED IN THE MEDWATCH FORM, AND THAT THEY EXCHANGED THE BLOOD PUMP FOR A SUSPECTED DEFECT OF THE MEMBRANE. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED BLOOD PUMP WAS NOT RETURNED TO BERLIN HEART AND WAS, THEREFORE, NOT AVAILABLE FOR EXAMINATION, AND WE ARE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    ACCORDING TO THE SITE, A PATIENT IMPLANTED WITH AN LVAD EXCOR BLOOD PUMP WAS TAKEN TO THE OPERATING ROOM TO INSERT A RVAD ON (B)(6) 2020. AT 1630 HOURS, THE PATIENT WAS ON BVAD SUPPORT, AND IT WAS NOTICED THAT MEMBRANE ON THE P10P-001 PUMP APPEARED TO BE RUPTURED. THE SURGEON BELIEVED IT MAY HAVE BEEN RUPTURED DURING PRIMING. ANOTHER PUMP WAS PRIMED, AND THE RVAD PUMP WAS EXCHANGED AT 1632 HOURS. THE RVAD WAS OFF FOR LESS THAN 30 SECONDS. ONCE BACK ON SUPPORT, BOTH VADS FUNCTIONED NORMALLY, AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117174 BLOOD PUMP PU VALVES 10 ML, IN/OUT 6 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR