BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RVL-2100 B VACUUM RELIEF VALVE

    MDR report key: 5022221 · Received August 21, 2015

    Report

    Report Number
    1649914-2015-00058
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 24, 2015
    Report Date
    September 4, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION WITH AND WITHOUT MAGNIFICATION DID NOT SHOW ANY DEFECTS. THE VALVE WAS ATTACHED TO A ROLLER PUMP FOR FUNCTIONAL TESTING AND FUNCTIONED AS PER SPECIFICATION. THE COMPLAINT CONDITION COULD NOT BE DUPLICATED. THE APPLICABLE LOT NUMBER FOR THE PART WAS NEVER PROVIDED AND COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE FOREIGN (MEXICAN) PRODUCT DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WITH THE CARDIOVASCULAR VALVE. THE REPORT STATED THE PERFUSIONIST ATTEMPTED TO INVESTIGATE/ISOLATE THE SOURCE OF THE ISSUE IN THE CIRCUIT AND DETERMINED THERE WAS RESTRICTED FLOW IN THE ONE-WAY VALVE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT WAS TAKEN OFF OF BYPASS AND THE VALVE WAS REPLACED. THE REPORT STATED THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE LOT NUMBER WAS NOT RECORDED AND IS UNKNOWN AT THE TIME OF THIS REPORT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555065 RVL-2100 B VACUUM RELIEF VALVE CARDIOVASCULAR SUCTION CONTROL VALVE DWD QUEST MEDICAL, INC. 4103202

    Patients

    Seq Age Sex Outcome Treatment
    1