BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR SET FOR CANNULAE Ø 6/ 9 MM

    MDR report key: 15014181 · Received July 14, 2022

    Report

    Report Number
    3004582654-2022-00032
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 14, 2022
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040591
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONNECTOR SET FOR CANNULAE, LOT 00116205, ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2022 (93 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR CONNECTOR SET, LOT 00116205 AND LOT WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    BERLIN HEART, GMBH WAS NOTIFIED BY THE SITE THAT DURING A CONNECTING SET CHANGE, A SMALL AMOUNT OF BLOOD ( LESS THAN 2 MLS ) WAS OBSERVED DURING THE FINAL CABLE TIE REMOVAL. THE CONNECTING SET WAS BEING EXCHANGED DUE TO THROMBUS. THE SIDE CUTTERS WERE KEPT IN THE SAME POSITION TO PROVIDE SLIGHT PRESSURE FOR PREVENTION OF FURTHER BLOOD LOSS. A STERILE FIELD WAS PREPARED, THE LVAD BLOOD PUMP WAS PAUSED, AND THE AFFECTED CONNECTING SET WAS EXCHANGED WITHOUT UNTOWARD EFFECT TO THE PATIENT. UPON REMOVAL, A SMALL LONGITUDINAL SLIT WAS SEEN (APPROX. 3 MM) AT THE POSITION OF THE CABLE TIE. OF NOTE, THE CABLE TIES WERE BEING REMOVED WITH THE SIDE CUTTERS. THE CLINIC DISPOSED OF THE EFFECTED CONNECTING SET TUBING, THEREFORE, THE PRODUCT IS NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061004 CONNECTOR SET FOR CANNULAE Ø 6/ 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH A06-009 00116205 04260090040591

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Male