BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET

    MDR report key: 5339832 · Received January 3, 2016

    Report

    Report Number
    1649914-2015-00114
    Event Type
    Injury
    Date Received
    January 3, 2016
    Date of Event
    November 23, 2015
    Report Date
    January 12, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE WITH THE MPS DELIVERY SET. SHE REPORTED THAT THE DELIVERY SET LEAKED DURING THE PROCEDURE. SHE SAID SHE DID NOT NOTICE UNTIL AFTER THE SURGERY WAS OVER WHEN SHE OPENED THE MPS CONSOLE DOOR AND NOTICED A DROP OF BLOOD ON THE FLOOR, IT WAS A VERY SMALL LEAK. THE PROCEDURE WAS ONLY AN HOUR LONG SO THERE WAS MINIMAL. THE REPORT STATED THAT THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0500715C08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention