BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV-2100B

    MDR report key: 4781999 · Received May 19, 2015

    Report

    Report Number
    1649914-2015-00025
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 20, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF A SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. HOWEVER, THE ROOT CAUSE FOR THE SAME COMPLAINT CONDITION HAS BEEN IDENTIFIED AND IS CURRENTLY BEING ADDRESSED IN THE CAPA SYSTEM. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. 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 INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE THEIR CUSTOMERS ENCOUNTERED RELATED TO THE SUCTION CONTROL VALVE. THIS VALVE IS PROVIDED BY THE MANUFACTURER AS AN OEM DEVICE FOR FURTHER PROCESSING/KITTING BY THE DISTRIBUTOR. THE REPORT STATED THERE WERE SEVERAL INCIDENTS THAT OCCURRED AT SEPARATE HOSPITALS. THE DISTRIBUTOR RECEIVED INFORMATION THAT DURING PRIMING OF THE CIRCUIT, WHEN THE PLASMALYTE BAG WAS SPIKED A LEAK WAS OBSERVED FROM THE ONE-WAY PRESSURE VALVE. IT WAS REPORTED THAT THE CUSTOMER WAITED TO SEE IF THE LEAK WAS ONLY TEMPORARY; HOWEVER, FOLLOWING PRIMING THE VALVE WAS OBSERVED TO BE CONTINUALLY LEAKING AT ABOUT 1 DROP/SECOND. AS A RESULT OF THE EVENT THE HOSPITAL STAFF CHANGED OUT THE VALVE. IT IS UNKNOWN IF ALL THE VALVES WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. REFERENCE MANUFACTURER REPORTS: 1649914-2015-00017 THROUGH 1649914-2015-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324982 RLV-2100B CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202 047766

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention