BEUDAMED
    FDA Adverse Event Other Summary report: N

    MPS 2 CONSOLE

    MDR report key: 2104972 · Received April 12, 2011

    Report

    Report Number
    1649914-2011-00003
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY INDICATED THAT THERE WAS NO CONSEQUENCES OR IMPACT TO PT; HOWEVER, A PRODUCT PROBLEM REPORT WAS SUBMITTED. IN RESPONSE, QUEST DETERMINED BY A FIELD EVAL OF THE PRODUCT THAT THE COLD/WARM TEMPERATURE SWITCH WAS DIFFICULT TO ENGAGE; HOWEVER, THE INSTRUMENT'S WARM MODE HAS THE FEATURE TO CONTROL THE TEMPERATURE DOWN TO 4 DEGREES CELSIUS, IF UTILIZED. IN ORDER TO ADDRESS THE CUSTOMER'S CONCERNS AND ENSURE PROPER PERFORMANCE, THE DISPLAY BOARD WAS REPLACED TO ADDRESS THE INTERMITTENT SWITCH FAILURE.

    Description of Event or Problem · 1

    USER FACILITY PROVIDED THE FOLLOWING INFO: "PT HAVING CORONARY BYPASS SURGERY. CARDIOPLEGIA HAD BEEN ADMINISTERED. PUMP PERFUSIONIST WAS RUNNING PERFUSION PUMP DURING PROCEDURE AND IT WAS FAILING TO COOL THE CARDIOPLEGIA CORRECTLY AND MD NOTED THE HEART WAS NOT AS COOL AS USUAL. PUMP PERFUSIONIST COULD NOT GET THE BOARD ON THE EQUIPMENT TO WORK. MACHINES WERE SWITCHED OUT AND THE NON-FUNCTIONING MACHINE WAS SEQUESTERED. QUEST SERVICE ENGINEER SERVICED THE PUMP ON (B)(6) 2011; HE ADVISED OUR BIO-MED REP THAT HE WAS ABLE TO REPRODUCE THE FAILURE AS DESCRIBED BY THE PUMP PERFUSIONIST. HE COULD NOT SWITCH THE TOGGLE TO COLD. HE REPLACED THE CIRCUIT BOARD AND VERIFIED OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS 2 CONSOLE HEAT EXCHANGER + PUMP + PRESSURE GAUGE DTR QUEST MEDICAL, INC. 5201260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR