BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET

    MDR report key: 4912950 · Received July 14, 2015

    Report

    Report Number
    1649914-2015-00055
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 22, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. DEVICE EVALUATION CONFIRMED THE SET WAS LEAKING. VISUAL EXAMINATION FOUND A SMALL CUT ON THE BACK SIDE OF THE BLOOD INLET AREA OF THE PUMP CASSETTE. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE IDENTIFIED. REVIEW OF INTERNAL MANUFACTURING AND TEST RECORDS DID NOT FIND ANY SIMILAR INCIDENTS OF A CUT OR PUNCTURE TO DEVICES. 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 PRIOR TO A PROCEDURE STARTING. HE STATED THAT DURING PRIMING OF THE SYSTEM WITH THE DISPOSABLE SET INSTALLED, HE OBSERVED THE SET LEAKING FROM THE LOWER POUCH CHAMBER. AS A RESULT A DIFFERENT DISPOSABLE SET WAS USED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE AFFECTED DEVICE WAS RETAINED AND SENT TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455659 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0485895M04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention