BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET

    MDR report key: 6136297 · Received November 30, 2016

    Report

    Report Number
    1649914-2016-00059
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DECONTAMINATION TO IDENTIFY THE LEAK COMPLAINT SAMPLE WAS FILLED WITH WATER AND MANUALLY PRESSURIZED TO IDENTIFY ANY LEAKS. A SMALL PINHOLE LEAK WAS OBSERVED ON CRYSTALLOID SIDE ON PUMP CASSETTE NEAR THE BLOOD OUTLET. THE CAUSE OF PINHOLE LEAKS CAN BE PROCESS VARIATION WHICH COULD LEAD TO WEAK POINTS WITHIN WELD SEAM AREA. 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 DELIVERY SET LEAKED BLOOD. THERE WERE NO FURTHER DETAILS PROVIDED AS TO WHEN THE ALLEGED EVENT OCCURRED DURING THE PROCEDURE OR THE AMOUNT OF BLOOD LOST. THERE WERE NO PATIENT COMPLICATIONS 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
    785271 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0519346G08 00634624501126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention