BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 30 ML IN/OUT Ø9 MM

    MDR report key: 8595819 · Received May 9, 2019

    Report

    Report Number
    3004582654-2019-00037
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: 3008454189) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). BASED ON INFORMATION RECEIVED FROM THE DISTRIBUTOR, PART OF THE EVENT DESCRIPTION (BOX B5) NEEDS TO BE CHANGED AS FOLLOWS: UPON REVIEW OF THE AVAILABLE INFORMATION AND TAKING INTO ACCOUNT THAT THE PATIENT DEVELOPED A LUNG EDEMA AND HAD TO BE INTUBATED DUE TO AN ARTERIAL SATURATION OF ABOUT 50%, BERLIN HEART CA RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. THE AFFECTED BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC ON (B)(6) 2019. THE PATIENT'S CONDITION IMPROVED AND COULD BE EXTUBATED ON (B)(6) 2019. HOWEVER, THE PATIENT SUFFERED A HEMORRHAGIC CVA AND DIED ON (B)(6) 2019. THE CLINIC PROVIDED BERLIN HEART WITH TWO VIDEOS OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. UPON EVALUATION, NO FUNCTIONAL IMPAIRMENT COULD BE NOTICED. THE BLOOD PUMP FILLED AND EMPTIED COMPLETELY. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NO ABNORMALITIES WERE DETECTED DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE ON THE TEST STAND. THE BLOOD PUMP MET ITS FUNCTIONAL SPECIFICATION AND THE MOVEMENT OF THE MEMBRANES AND THE VALVES WERE ASSESSED TO BE NORMAL. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE MEMBRANE LAYERS LAY PARALLEL TO ONE ANOTHER AND NONE OF THE LAYERS HAD ANY VISIBLE ABNORMALITY. THE BLOOD PUMP CORRESPONDED TO ITS SPECIFICATION WITH NO DEVIATIONS. A RELATION BETWEEN THE EXCOR BLOOD PUMP AND THE DETERIORATION OF THE GENERAL CONDITION OF THE PATIENT COULD NOT BE DETERMINED.

    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 IN USE BY THE PATIENT FROM (B)(6) 2019 TO (B)(6) 2019 (31 DAYS). THE PATIENT CONDITION DECLINED LEADING TO DEATH ON (B)(6) 2019 DUE TO A HEMORRHAGIC CVA. 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. INSPECTION OF THE RETURNED BLOOD PUMP IS CURRENTLY ONGOING AND A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART (B)(4) WAS CONTACTED BY OUR (B)(4) DISTRIBUTOR TO REPORT A SUSPECTED INSUFFICIENCY OF THE OUTFLOW VALVE OF THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC PROVIDED BERLIN HEART CLINICAL AFFAIRS (CA) PERSONNEL WITH VIDEOS OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. UPON REVIEW OF THE AVAILABLE INFORMATION, BERLIN HEART CA RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. THE AFFECTED BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC ON (B)(6) 2019. LATER IN THE DAY, THE PATIENT STARTED BLEEDING FROM THE THROAT AND HAD TO BE INTUBATED DUE TO THE PATIENT'S ARTERIAL SATURATION HAVING BEEN ABOUT 50%. THE PATIENT ALSO DEVELOPED A LUNG EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388020 EXCOR BLOOD PUMP PU VALVES, 30 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening