BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET

    MDR report key: 4243650 · Received November 11, 2014

    Report

    Report Number
    1649914-2014-00057
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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 PERFUSIONIST AT REGINA GENERAL HOSPITAL (B)(6) REPORTED A PROBLEM WITH THE MPS DISPOSABLE. HE REPORTED THE ISSUE OCCURRED WHEN HE WAS ABOUT TO ARREST THE PATIENT'S HEART. HE STATED IT APPEARED THE VALVE ON THE ARREST POUCH DID NOT OPEN CORRECTLY. THE PERFUSIONIST REPORTED HE CHANGED OUT THE DELIVERY SET AND WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE LOT NUMBER OF THE APPLICABLE DELIVERY SET WAS NOT RECORDED BY THE HOSPITAL. 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
    727878 MPS DELIVERY SET CARDIOPULMONARY BYPASS HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102AS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention