BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECC CIRCULATORY PACK WITH QUADRIOX ID - BEQ-TOP 47501

    MDR report key: 5846775 · Received August 4, 2016

    Report

    Report Number
    2248146-2016-00059
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    July 12, 2016
    Report Date
    January 30, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WE'RE UNABLE TO COMPLETE AN EVALUATION ON THE AFFECTED PRODUCT. THE CUSTOMER INDICATED IT IS NOT RETURNING FOR OUR INVESTIGATIONAL EFFORTS HOWEVER IF THAT CHANGES OR ADDITIONAL INFORMATION IS MADE AVAILABLE A SUPPLEMENTAL REPORT WILL BE PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE WAS NOT ENTERED IN THE INITIAL MDR. MANUFACTURER DATE: 07/13/2016.

    Description of Event or Problem · 1

    WHILE DOING AN ECLS, THE CUSTOMER REPORTED TO FIND A KINK IN THE TUBING OF THE CUSTOM PACK ABOUT 10 INCHES POST OXYGENATOR. THE KINK WAS CUT OUT AND THE PRODUCT WAS USED TO CONTINUE THE PROCEDURE.

    Description of Event or Problem · 1

    WHILE DOING AN ECLS, THE CUSTOMER REPORTED TO FIND A KINK IN THE TUBING OF THE CUSTOM PACK ABOUT 10 INCHES POST OXYGENATOR. THE KINK WAS CUT OUT AND THE PRODUCT WAS USED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500706 ECC CIRCULATORY PACK WITH QUADRIOX ID - BEQ-TOP 47501 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention