BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BLOOD TUBE SET

    MDR report key: 17540471 · Received August 14, 2023

    Report

    Report Number
    3013536188-2023-00006
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 14, 2023
    Manufacturer
    QUANTA DIALYSIS TECHNOLOGIES LTD
    Product Code
    FKY
    PMA / PMN Number
    K210661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). QUANTA IS CURRENTLY INVESTIGATING THE REPORTED FAULT AND WILL PROVIDE INVESTIGATION RESULTS UPON CONCLUSION. THE SAMPLE IS PRESENTLY IN TRANSIT ANDUPON RECEIPT WE WILL PROVIDE ADDITIONAL INFORMATION. QUANTA TECHNICAL TEAM WILL CONTINUE TO INVESTIGATE THE ROOT CAUSE OF THE REPORTED ISSUE. A CAPA HAS BEEN INITIATED TO IDENTIFY AND DEFINE ANY ADDITIONAL MITIGATIONS TO BE ADDED TO FURTHER MITIGATE THE RISKS ASSOCIATED WITH THIS ISSUE. THE SAMPLE IS PRESENTLY IN TRANSIT AND QUANTA WILL DO A THOROUGH PRODUCT INVESTIGATION.

    Description of Event or Problem · 0

    A HOME HEMODIALYSIS PATIENT REPORTED THAT DURING THEIR HEMODIALYSIS TREATMENT ON (B)(6), 2023, THEY SUFFERED A BLOOD LOSS WHILE ON DIALYSIS. THE PATIENT ADVISED THAT BLOOD LEAK WAS COMING FROM THE TOP OF THE PERISTALTIC LOOP ON THE BLOOD TUBE SET. THE PATIENT WAS UNABLE TO COMPLETE TREATMENT. THE PATIENT ESTIMATED LOSING ROUGHLY 500ML OF BLOOD. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION DURING INCIDENT; HOWEVER, THE PATIENT LATER COMMUNICATED WITH THEIR RENAL UNIT AND WILL CONTINUE TO DO TREATMENT IN-CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354878 DISPOSABLE BLOOD TUBE SET DISPOSABLE BLOOD TUBE SET FKY QUANTA DIALYSIS TECHNOLOGIES LTD SC-14358 2303SA211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other