BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DISPOSABLE

    MDR report key: 3884188 · Received May 20, 2014

    Report

    Report Number
    1649914-2014-00025
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FOREIGN DISTRIBUTOR ((B)(6)) REPORTED A LEAKAGE ISSUE WITH THE MPS DISPOSABLE DELIVERY SET FROM ONE OF THEIR CUSTOMERS. THE HOSPITAL REPORTED A LEAKAGE ORIGINATING AT THE CONNECTION BETWEEN THE "MEDICAL SOLUTION BAG" (EITHER ARREST AGENT CASSETTE OR ADDITIVE CASSETTE) AND THE HEAT EXCHANGER. THE CUSTOMER REPORTED TIGHTENING THE CONNECTOR AGAIN BUT THE ALLEGED LEAK PERSISTED. IT WAS REPORTED THAT THE DISPOSABLE SET WAS USED FOR THE ENTIRE PROCEDURE WITH NO IMPACT TO THE PATIENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT RECORDED BY THE CUSTOMER AND IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298697 MPS DISPOSABLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention