BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 4106037 · Received September 22, 2014

    Report

    Report Number
    1649914-2014-00046
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 1, 2014
    Manufacturer
    QUEST MEDICAL INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE APPLICABLE LOT WAS REVIEWED AND THERE WERE NO DEVICES REJECTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. THERE WERE NO DEVICES OF THE SAME LOT NUMBER REMAINING IN INVENTORY FOR PHYSICAL 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' HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE FOREIGN DISTRIBUTOR ((B)(6)) REPORTED A LEAKAGE ISSUE WITH THE MPS DISPOSABLE DELIVERY SET FROM ONE OF THEIR CUSTOMERS. THE HOSPITAL REPORTED A LEAKED FLUID WAS FOUND ON THE MPS CONSOLE, JUST BELOW THE JOINT BETWEEN THE HEAT EXCHANGER AND THE ARREST CHAMBER (YELLOW). THE CUSTOMER REPORTED THE LEAK WAS DISCOVERED AT THE COMPLETION OF THE 3RD OR 4TH ADMINISTRATION OF CARDIOPLEGIC SOLUTION DURING THE PROCEDURE. THE REPORT STATED THE MEDICAL STAFF WIPED THE LEAKED FLUID WITH GAUZE, AND DUE TO THE YELLOW COLOR OF THE FLUID SURMISED IT WAS POTASSIUM SOLUTION FROM THE ARREST CHAMBER. IT WAS REPORTED THAT THE MEDICAL STAFF RETIGHTENED THE JOINT COMPONENT OF THE DISPOSABLE SET AND DID NOT OBSERVE ANY ADDITIONAL LEAKAGES DURING THE PROCEDURE. IT WAS REPORTED THAT THE DISPOSABLE SET WAS USED FOR THE ENTIRE PROCEDURE WITH NO IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587344 MPS DELIVERY SET CPBP HEAT EXCHANGER DTR QUEST MEDICAL INC. 5001102 0465044A01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention