BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV-2100 VACUUM RELIEF VALVE

    MDR report key: 6100637 · Received November 14, 2016

    Report

    Report Number
    1649914-2016-00055
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 17, 2016
    Report Date
    December 9, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    UDI-DI
    20634624413225
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO MORE DEVICES OF THE SAME LOT REMAINING IN INVENTORY FOR EVALUATION. 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

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WERE NO MORE DEVICES OF THE SAME LOT REMAINING IN INVENTORY FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE WAS PART OF A "SUCKER LINE", A NEGATIVE PRESSURE LINE USED DURING AN ECMO PROCEDURE. THE REPORT STATED THAT THE ONE-WAY VALVE WAS STUCK OPEN, AND TO RESOLVE THE ISSUE A CAP WAS PLACED ON THE NEGATIVE PRESSURE RELEASE AND ANOTHER VALVE WAS PLACED PROXIMAL TO THE OPEN VALVE. THE REPORT STATED THAT BLOOD WAS LOST THAT REQUIRED A BLOOD TRANSFUSION TO THE PATIENT AND AN ACUTE PRESSURE DROP WAS OBSERVED AS A RESULT OF THE ALLEGED EVENT. THE REPORT WAS COMPLETED AND NO FURTHER PATIENT IMPACT WAS REPORTED. THE DEVICE WAS DISCARDED BY THE END-USER AND NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR EVALUATION. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750611 RLV-2100 VACUUM RELIEF VALVE CARDIOPULMONARY SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202 050562 20634624413225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention