BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 3371576 · Received September 6, 2013

    Report

    Report Number
    1649914-2013-00045
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT' 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 REPORTED A POSSIBLE LEAKAGE ISSUE WITH AN MPS DISPOSABLE DELIVERY SET. THE PERFUSIONIST REPORTED THE DEVICE HAD A BLOOD-TO-WATER LEAK. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443220 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0444983E02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention