BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECC 3/8" PACK

    MDR report key: 3895976 · Received May 15, 2014

    Report

    Report Number
    2248146-2014-00078
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 18, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED, THEREFORE NO EVAL WAS PERFORMED TO CONFIRM THE REPORTED PROBLEM. BASED ON THE DESCRIPTION OF THE EVENT, THE FACILITY USED "METHALINE" BLUE ON THE PT JUST PRIOR TO INITIATING THERAPY WITH THIS DEVICE. THE INSTRUCTIONS FOR USE STATE IN SECTION 4, WARNINGS AND PRECAUTIONS; "WHEN USING THE OXYGENATOR, METHYLENE BLUE MUST NOT BE ADMINISTERED IMMEDIATELY BEFORE OR DURING PERFUSION." THE USE OF METHALINE BLUE AFFECTS THE PERMEABILITY OF THE MEMBRANE FIBERS IN THE OXYGENATOR WHICH COULD LEAD TO NEGATIVE CONSEQUENCES FOR THE PT. DEVICE HISTORY RECORDS DO NOT INDICATE ANY NON-CONFORMANCES RELATED TO THIS EVENT. IF THE PRODUCT IS RETURNED OR ADD'L INFO RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PT HAD BEEN GIVEN METHALINE BLUE, WHICH IS CONTRAINDICATED FOR QUADROX ID, PRIOR TO GOING ON ECLS. THE RESPIRATORY THERAPIST NOTICED THE TEMPERED WATER GOING THROUGH THE WATER LINES TO THE HEATHER COOLER HAD A SLIGHT BLUE COLOR. THE PT CAME OFF ECLS SUCCESSFULLY, WITH NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291278 ECC 3/8" PACK CARDIOPULMONARY DEVICE DWE DATASCOPE CORP. BEQ-TOP-33700 16358-06

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR