BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS® DELIVERY SET WITH 6 FT. DELIVERY TUBING

    MDR report key: 5208853 · Received November 6, 2015

    Report

    Report Number
    1649914-2015-00095
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 28, 2015
    Report Date
    November 6, 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
    MD, 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 PUMP CASSETTE WAS ATTACHED WITH AIR SOURCE AND DUNK TESTED IN WATER TO IDENTIFIED LEAK. THE LEAKING WAS IDENTIFIED BELOW THE BLOOD INLET BUSHING AND DELAMINATION OF WELD SEAM AREA CONFIRMING 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 WHILE GIVING THE FIRST DOSE. THE REPORT STATED THE CROSS CLAMP WAS ON AND THE PERFUSIONIST WAS ABLE TO ARREST THE HEART WITH MINIMAL BLOOD LOSS. THE PERFUSIONIST STATED THAT AFTER THE HEART WAS ARRESTED THEY CHANGED OUT THE DISPOSABLE DELIVERY SET WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737565 MPS® DELIVERY SET WITH 6 FT. DELIVERY TUBING CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102-AS 0495525G02 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention