BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET

    MDR report key: 5290847 · Received December 11, 2015

    Report

    Report Number
    1649914-2015-00107
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K953838
    Removal / Correction Number
    Z-0361-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. 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 AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. HE STATED THAT THE DEVICE LEAKED DURING USE, WITH THE LEAKAGE COMING FROM THE BLOOD INLET SIDE. THE REPORT STATED HE CHANGED THE DISPOSABLE DEVICE FOR ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT ISSUES REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820238 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0497255S04 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention