BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 5352108 · Received January 7, 2016

    Report

    Report Number
    1649914-2015-00118
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 8, 2015
    Report Date
    February 26, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CONFIRMED THE ALLEGED TEMPERATURE ISSUE; HOWEVER, THE ALLEGED BACK-FLOW ALARMS COULD NOT BE DUPLICATED. THE CIRCULATION PUMP/MOTOR WAS STALLING WHICH IN TURN CAUSED THE TEMPERATURE ALARMS. THE CIRCULATION MOTOR WAS REPLACED AND THE UNIT RETURNED TO SERVICE. THE CAUSE OF THE BACK-FLOW ALARMS IS UNKNOWN.

    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 MPS2 CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE HAD BEEN DISPLAYING ERROR CODES ("ARREST AGENT BACKFLOW" AND "ADDITIVE PRIME BACKFLOW") DURING RECENT CASES. THE REPORT ALSO STATED THAT THE CONSOLE DISPLAYED HEATER ALARMS AND SHUT OFF THE INTERNAL HEATER DURING THE LAST PROCEDURE. IN ALL INSTANCES THE PERFUSIONIST CONTINUED TO USE THE CONSOLE AND COMPLETED THE PROCEDURE WITH NO PATIENT COMPLICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR PREVENTIVE MAINTENANCE WORK AND WAS ABLE TO EVALUATE THE CONSOLE AND CONFIRM THE ALARM CODES/ERRORS IN THE LOG DATA. THE CONSOLE WILL BE SHIPPED BACK TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10141 MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability