BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM

    MDR report key: 16342446 · Received February 9, 2023

    Report

    Report Number
    3008454189-2023-00003
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(4), IS IN USE ON THE PATIENT FROM (B)(6) 2022 UNTIL (B)(6) 2023 (57 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    SITE CONTACTED BHI CLINICAL AFFAIRS ON 1.18.23 WITH CONCERNS ABOUT WORSENED SQUEAKING OF THE BLOOD PUMP. SITE REPORTED THAT THE INFLOW VALVE HAD BEEN SQUEAKING OVER A COUPLE OF MONTHS AND ONLY RESOLVED ITSELF WITH MILD PINCHING OF THE INFLOW VALVE. HOWEVER, SITE REPORTED THAT SQUEAKING WAS NOW NOTED AT BOTH INFLOW AND OUTFLOW VALVES. THE SITE WAS CONCERNED BECAUSE THE NOISE HAS BECOME INCREASINGLY LOUDER OVER THE LAST COUPLE OF DAYS AND LDH/PFHGB HAVE BEEN RISING. (B)(6) 2023; LDH 629, PFHGB <30; (B)(6) 2023; LDH 1173, PFHGB <30; (B)(6) 2023; LDH 1344, PFHGB 120; (B)(6) 2023; LDH 1713, PFHGB 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816825 BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Other