BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-TOP 33704 ECLS PACK

    MDR report key: 7008082 · Received November 7, 2017

    Report

    Report Number
    2248146-2017-00621
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 6, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS DISCARDED BY THE USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING THE CIRCUIT OF THE BEQ-TOP 33704 ECLS PACK HAD A LEAK FROM THE DE AIRING PORT AND WAS NOTICED ON (B)(6) . THIS WAS NOTED PRIOR TO USE AND THEREFORE NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787803 BEQ-TOP 33704 ECLS PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000028631

    Patients

    Seq Age Sex Outcome Treatment
    1