BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV-2100 "B" VACUUM RELIEF VALVE

    MDR report key: 5339684 · Received January 2, 2016

    Report

    Report Number
    1649914-2015-00112
    Event Type
    Injury
    Date Received
    January 2, 2016
    Date of Event
    December 2, 2015
    Report Date
    December 23, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED NOR RECORDED BY THE USER FACILITY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE WAS ATTACHED TO A ROLLER PUMP AND TESTED AT BOTH HIGH AND LOW SPEEDS, BUT NO LEAKS WERE OBSERVED. THE DEVICE WAS TESTED A VARIOUS PRESSURE SETTINGS OF NEGATIVE AND POSITIVE PRESSURES AND A LEAK WAS OBSERVED AT A POSITIVE PRESSURE OF 1012MMHG. THIS DEVICE IS DESIGNED TO PROVIDE PRESSURE RELIEF AT A NEGATIVE PRESSURE OF -200MMHG AND AT A POSITIVE PRESSURE OF <1300MMHG. VISUALLY THERE WAS DRIED/CRYSTALLIZED BLOOD FOUND ON THE UMBRELLA VALVE EDGES. THE CAUSE OF THE REPORTED DEFECT COULD NOT BE DETERMINED. THE COMPLAINT CONDITION COULD NOT BE DUPLICATED. 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 FOREIGN DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED WITH THE SUCTION VALVE. THEY REPORTED THAT THEIR CUSTOMER (HOSPITAL PERFUSIONIST) REPORTED THAT THE VALVE LEAKED DURING USE. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69 RLV-2100 "B" VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention