BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCOR BLOOD PUMP PU VALVES 25 ML IN/OUT 9 MM

    MDR report key: 3755485 · Received July 10, 2013

    Report

    Report Number
    3004582654-2013-00025
    Event Type
    Other
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BERLIN HEART INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4) (MFR). THE EXCOR BLOOD PUMP SN (B)(4) WAS USED FROM (B)(6) 2013 FOR 29 DAYS. THE MFR OF THE BLOOD PUMP REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP SN (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO THE SPEC AND NO ABNORMALITIES WERE FOUND IN THE RECORDS. VISUAL INSPECTION OF THE RETURNED BLOOD PUMP CONFIRMED THE CUSTOMER OBSERVATION. THERE WAS NO FLUID IDENTIFIED BETWEEN THE BLOOD SIDE LAYER AND THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. HOWEVER, INITIAL INSPECTION OF THE PUMP BY THE DISTRIBUTOR BERLIN HEART INC CONFIRMED THE DROPLETS OF FLUID BETWEEN THE BLOOD SIDE LAYER AND THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. THE INTEGRITY OF THE RETURNED BLOOD PUMP WAS TESTED BY PRESSURIZATION. NO LEAKAGE COULD BE DETECTED. AFTER OPENING THE RETURNED BLOOD PUMP THE BLOOD SIDE LAYER AND ALSO THE AIR SIDE AND MIDDLE LAYERS OF THE TRIPLE LAYER MEMBRANE WERE TESTED FOR THEIR INTEGRITY. NO LEAKAGE OR DAMAGE IN ANY ONE OF THE MEMBRANE LAYERS COULD BE DETECTED. THE EVAL OF THE BLOOD PUMP SN (B)(4) SHOWS THAT NO PERFORMANCE LIMITATIONS OR DAMAGE WAS PRESENT. ALL THREE LAYERS OF THE MEMBRANE WERE INTACT. REF IMP 3008454189-2013-00023.

    Description of Event or Problem · 1

    SITE CONTACTED CA TO NOTIFY THAT IT IS OBSERVED THAT THERE IS A CLEAR FLUID IN THE PUMP, LOCATED ON THE INNER SURFACE SEEN WHERE THE MEMBRANES CONNECT TO THE PUMP HOUSING. CA VISITED THE SITE TO OBSERVE THIS PHENOMENON IN PERSON (LOCAL). CA OBSERVED THE PHENOMENON AS WELL. IT APPEARED TO BE "CONDENSATION" IN THE SPACE BETWEEN THE BLOOD MEMBRANE AND THE AIR MEMBRANES. AS THE LVAD (SN (B)(4)) WAS TILTED UP, SOME OF THIS FLUID COLLECTED ON THE INFERIOR MOST ASPECT OF THE "RING" OF THE PUMP. IT CREATED APPROX 15MM BY 3MM "POOL" THAT WAS MOBILE WITHIN THIS SPACE. NO MOISTURE WAS SEEN ON THE AIR SIDE OF THE PUMP OR IN THE DRIVELINES. IT WAS DECIDED BY THE CLINICAL TEAM TO EXCHANGE THE LVAD. IT WAS NOTED BY THE CLINICAL STAFF THAT THE PT HAD BEEN ON AN EXCURSION OUTSIDE (90 DEGREES F, 65% HUMIDITY, 30.06"HG) EARLIER THAT DAY. UPON PREPARING FOR THE LVAD EXCHANGE, IT WAS OBSERVED THAT THE SAME CONDITION COULD BE SEEN ON THE RVAD (SN (B)(4), 3004582654-2013-00025). THE CLINICAL TEAM DECIDED TO EXCHANGE BOTH VADS. THE SETTINGS ON THE IKUS AT THE TIME OF THIS EVENT WERE L/200/-30/72/40% R/140/-30/50/45%. NO CHANGE IN PT CONDITION OR PUMP FUNCTION WAS OBSERVED DURING THIS EVENT (PER (B)(6) MD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319427 EXCOR BLOOD PUMP PU VALVES 25 ML IN/OUT 9 MM VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH P25P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR