BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9MM

    MDR report key: 7129312 · Received December 19, 2017

    Report

    Report Number
    3004582654-2017-00033
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS USED IN A PATIENT FROM (B)(6) 2017 (34 DAYS). MANUFACTURER OF THE PUMP HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE RETURNED BLOOD PUMP WAS TESTED ON THE PUMP TEST BENCH AND MET ITS REQUIRED FUNCTIONAL SPECIFICATION. THE BLOOD PUMP FILLED AND EMPTIED COMPLETELY. THIS IS INDICATIVE OF AN INTACT AIR-SIDE LAYER. THE AIR-SIDE MEMBRANE APPEARED SMOOTH, WITH NO CREASES, IN THE END-SYSTOLIC AS WELL AS END-DIASTOLIC POSITION, INDICATING THAT THE MIDDLE LAYER WAS ALSO INTACT. NO FLUID WAS DETECTED IN THE MEMBRANE INTERSTICES, WHICH ALSO INDICATES THAT THE BLOOD-SIDE MEMBRANE HAD NO DEFECTS. ALL THREE LAYERS OF THE TRIPLE LAYER MEMBRANE OF THE BLOOD PUMP DISPLAYED NO DEFECTS. DURING THE TESTING, THE REPORTED PUMPING SOUND WAS CONFIRMED, BUT PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP, SINCE THESE PUMPS WERE MADE BY OPERATORS MANUALLY. WE ARE UNABLE TO ESTABLISH EXACT CAUSE FOR THE SOUND REPORTED, HOWEVER, REPORTED PUMPING SOUND DID NOT AFFECT THE FUNCTION OF THE PUMP. IN REGARDS TO THE GRAPHITE OBSERVED, A MICROSCOPIC EXAMINATION OF THE RETURNED PUMP REVEALED A SMALL AMOUNT OF LOOSE GRAPHITE POWDER IN THE AIR CHAMBER. DURING PRODUCTION OF THE EXCOR BLOOD PUMPS, GRAPHITE POWDER IS APPLIED ON BOTH SURFACES OF THE AIR-SIDE AND MIDDLE LAYER AND ONLY ON THE INNER SURFACE OF THE BLOOD-SIDE LAYER OF THE MEMBRANE. ONCE THE PUMP IS IN USE ON A PATIENT, GRAPHITE POWDER PARTICLES MIGHT COME LOOSE FROM THE OUTER SURFACE OF THE AIRSIDE LAYER. PREVIOUSLY (REF. 3004582654-2017-00025 AND 3004582654-2017-00026) BLOOD PUMP WITH VISIBLE LOOSE GRAPHITE WAS TESTED IN A MOCK LOOP TO OBSERVE IF ANY MORE GRAPHITE ABRASION OR MEMBRANE DAMAGE COULD OCCUR. AFTER 26 DAYS OF TESTING, THE AMOUNT OF PARTICLES REMAINED STABLE AND WITHOUT MUCH CHANGE SINCE THE BEGINNING OF THE TEST. THEREFORE GRAPHITE PARTICLE COME LOOSE AT VERY BEGINNING OF PUMP USE AND STABILIZE AFTERWARD. SINCE THE ABNORMALITIES CAUSED UNCERTAINTY FOR THE CUSTOMER, WE RECOMMENDED THE REPLACEMENT OF BOTH BLOOD PUMPS. THIS ANALYSIS CONCERNS THE PATIENT'S LEFT EXCOR BLOOD PUMP; THE RIGHT EXCOR BLOOD PUMP WILL BE PROCESSED UNDER 3004582654-2017-00034.

    Description of Event or Problem · 0

    THE CLINIC CONTACTED BERLIN HEART INC. TO INFORM THAT BOTH EXCOR BLOOD PUMPS OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION EMITTED ABNORMAL SOUNDS DURING OPERATION. IN ADDITION,AN ABRASION WAS VISIBLE IN THE AIR CHAMBERS OF BOTH BLOOD PUMPS. THE CLINIC REPORTED THAT THE FUNCTION OF THE TWO EXCOR BLOOD PUMPS WAS NOT IMPAIRED AND THAT THE PATIENT WAS ALWAYS SUFFICIENTLY SUPPORTED. THE CLINIC PROVIDED BERLIN HEART INC. WITH VIDEOS DESCRIBING THE EVENT. AFTER EVALUATING THE VIDEO WITH BERLIN HEART (B)(4), BERLIN HEART INC. ADVISED THE CLINIC TO EXCHANGE BOTH EXCOR BLOOD PUMPS. THE AFFECTED EXCOR BLOOD PUMPS WERE IMMEDIATELY EXCHANGED BY TRAINED PERSONNEL IN THE CLINIC. THE REPLACEMENT OF THE EXCOR BLOOD PUMPS WAS WITHOUT COMPLICATIONS AND THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910924 EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR