BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC SURGERY PACK

    MDR report key: 3912197 · Received May 13, 2014

    Report

    Report Number
    2248146-2014-00073
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 15, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED OR ROOT CAUSE IDENTIFIED. DEVICE HISTORY WAS REVIEWED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED COMPLAINT. THE FACILITY WAS ABLE TO USE THE KIT BY SWITCHING OUT THE RESERVOIR WITHOUT INCIDENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TINY LEAK ON THE OUTLET OF THE VENOUS RESERVOIR. THIS FACILITY IS A SPECIALITY ACCOUNT AND THEY ARE INSTRUCTED TO SELF ZIP TIE ALL CONNECTIONS. IT WAS DURING THIS PROCESS THAT THE CUSTOMER FEELS THE ZIP TIE WAS OVERTIGHTENED, WHICH RESULTED IN A CRACK IN THE PLASTIC. THE RESERVOIR WAS REPLACED AND THE CASE COMPLETED WITHOUT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285620 CARDIAC SURGERY PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BO-TOP 36500 16593-17

    Patients

    Seq Age Sex Outcome Treatment
    1