BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET

    MDR report key: 5208850 · Received November 6, 2015

    Report

    Report Number
    1649914-2015-00100
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 27, 2015
    Report Date
    November 2, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624501126
    PMA / PMN Number
    K953838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO DEVICES OF THIS LOT REMAINING IN INVENTORY FOR ANALYSIS. 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 RETURNED COMPLAINT SAMPLE WAS ATTACHED WITH FLUID DELIVERY SOURCE AND IDENTIFIED LEAK. THE LEAK WAS OBSERVED ON NON-FUNCTIONAL AREA OR PUMP CASSETTES. THE LOWER RADIUS WAS DELAMINATED INTERNALLY AND LEAK OUT THROUGH THE NONFUNCTIONAL AREA OF PUMP CASSETTES AND CONFIRMING THE COMPLAINT CONDITION. THE DEVICE HISTORY RECORDS FOR THIS LOT WAS REVIEWED AND THE INSPECTION REPORT SHOWED THAT NO MPS DISPOSABLE DEVICE WAS FOUND REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WAS REPORTED SIMILAR TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. SHE REPORTED THAT THE DELIVERY SET WAS OBSERVED TO BE LEAKING ABOUT 2/3 OF THE WAY THROUGH THE PROCEDURE. THE REPORT STATED THE VOLUME OF PATIENT BLOOD LOST TO BE BETWEEN 100-200ML. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE REPORT STATED THE DEVICE WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737988 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0496875G08 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention