BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS MYOCARDIAL PROTECTION SYSTEM DELIVERY SET

    MDR report key: 4392847 · Received January 7, 2015

    Report

    Report Number
    1649914-2014-00062
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 8, 2014
    Report Date
    January 13, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOUND THAT THE TOP HEAT EXCHANGER HOUSING/AA PORT APPEARED TO HAVE BEEN PRODUCED AT THE SUPPLIER AT THE HIGHER END OF THE NOMINAL RANGE. THIS MAY HAVE CAUSED THE HAIR LINE GAP BETWEEN THE MALE LUER OF THE CHECK VALVE AND THE INNER DIMENSION OF THE ADDITIVE PORT. DURING SIMULATED USE TESTING ON AN IN-HOUSE CONSOLE, ONLY A MINUSCULE LEAK WAS OBSERVED WITH THE TEST SAMPLE. A CPAR HAS BEEN INITIATED WITH THE SUPPLIER TO MODIFY THE CORE PINS TO BRING CLOSER TO THE NOMINAL VALUE FOR THE HOUSING.

    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.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING A PROCEDURE. SHE REPORTED THAT THE MPS CONSOLE WOULD NOT PASS THE INITIAL PRIMING STEPS WITH THE DELIVERY SET LEAKING (EITHER BLOOD OR A CLEAR FLUID). THE INITIAL INFORMATION PROVIDED STATED THAT THE MPS ALARM/FAILURE TO PASS PRIME WAS RELATED TO THE ALLEGED DELIVERY SET LEAKAGE. THE PERFUSIONIST STATED THIS EVENT HAS OCCURRED TWICE WITH 2 SEPARATE LOT NUMBERS (SEE ALSO MANUFACTURER REPORT NUMBER 1649914-2014-00063). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE HOSPITAL HAS INDICATED THE DELIVERY SET WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, THE SET HAS NOT YET BEEN RECEIVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12644 MPS MYOCARDIAL PROTECTION SYSTEM DELIVERY SET CARDIOPULMONARY BYPASS HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0474244G09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention