BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC SURGERY PACK BO-TOP 36500

    MDR report key: 6440628 · Received March 28, 2017

    Report

    Report Number
    2248146-2017-00022
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 2, 2017
    Report Date
    February 27, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT RECORD # (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND SO 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

    THE INITIAL REPORT STATED THAT THE MIDDLE STOPCOCK FAILED BY DRIPPING THROUGH THE BOTTOM. DRUGS WERE THEN ADDED THROUGH THE RESERVOIR. THERE WAS NO PATIENT INJURY, HOWEVER NO PATIENT INFORMATION WAS GIVEN. THE PRODUCT WAS DISCARDED AFTER THE CASE SO THEREFORE NO LOT # WAS GIVEN.

    Description of Event or Problem · 1

    THE INITIAL REPORT STATED THAT THE MIDDLE STOPCOCK FAILED BY DRIPPING THROUGH THE BOTTOM. DRUGS WERE THEN ADDED THROUGH THE RESERVOIR. THERE WAS NO PATIENT INJURY, HOWEVER NO PATIENT INFORMATION WAS GIVEN. THE PRODUCT WAS DISCARDED AFTER THE CASE SO THEREFORE NO LOT # WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223718 CARDIAC SURGERY PACK BO-TOP 36500 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1