BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BLOOD TUBE SET

    MDR report key: 17327354 · Received July 14, 2023

    Report

    Report Number
    3013536188-2023-00004
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 14, 2023
    Manufacturer
    QUANTA DIALYSIS TECHNOLOGIES LTD
    Product Code
    FKY
    PMA / PMN Number
    K210661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). QUANTA ARE CURRENTLY INVESTIGATING THE REPORTED FAULT AND WILL PROVIDE INVESTIGATION RESULTS UPON CONCLUSION. QUANTA TECHNICAL TEAM WILL CONTINUE TO INVESTIGATE THAT THE DEVICE PERFORMED AS INTENDED. QUANTA CONTINUE TO WORK WITH THE CLINIC TO GAIN FURTHER INFORMATION ON CIRCUMSTANCES LEADING UP TO THE EVENT.

    Description of Event or Problem · 0

    QUANTA WAS INFORMED ON (B)(6) 2023, THAT HEMODIALYSIS PATIENT ON (B)(6) 2023 SUFFERED A BLOOD LOSS WHILE ON DIALYSIS. IT WAS ESTIMATED THAT THE PATIENT LOST ABOUT 500MLS OF BLOOD. WHEN THIS WAS NOTICED THE PATIENT ADMINISTERED THEMSELVES A SALINE BOLUS TO INCREASE HIS BLOOD PRESSURE AND THEY STOPPED THE TREATMENT. THE PATIENT WAS NOT ADMITTED TO HOSPITAL FOLLOWING THE BLOOD LEAK BUT DID REPORT FEELING DIZZY INITIALLY AND FELT FINE AFTER SALINE BOLUS. DURING FOLLOW-UP, THE NURSE MENTIONED THAT THE CLAMP ON THE ANTICOAGULANT LINE WAS ENGAGED BUT IT DID NOT ALIGN CORRECTLY ON THE TUBING AND THEREFORE DIDN'T OCCLUDE THE LINE WHEN ENGAGED, AND NURSE CONFIRMED THAT THE CAP ON THE END OF THE ANTICOAGULANT LINE WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180587 DISPOSABLE BLOOD TUBE SET DISPOSABLE BLOOD TUBE SET FKY QUANTA DIALYSIS TECHNOLOGIES LTD SC-14358 2304SA232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other