BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 3145199 · Received May 30, 2013

    Report

    Report Number
    1649914-2013-00031
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED THAT THE MPS DISPOSABLE EXPERIENCED A POTASSIUM LEAK DURING A PROCEDURE. HE REPORTED THAT THE ALLEGED LEAK APPEARED TO ORIGINATE FROM THE CONNECTION OF THE TUBING AND THE POUCH. IT WAS REPORTED THAT THE SURGICAL TEAM HAD THE PATIENT ON BYPASS FOR ABOUT 30 MINUTES BEFORE THE ISSUE WAS DISCOVERED. THEY SWITCHED OUT DISPOSABLE CASSETTES AND COMPLETED THE PROCEDURE WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE LOT NUMBER OF THE AFFECTED DEVICE IS UNKNOWN. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237944 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention