BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BLOOD TUBE SET

    MDR report key: 17363957 · Received July 20, 2023

    Report

    Report Number
    3013536188-2023-00005
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 24, 2023
    Report Date
    July 20, 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). BASED ON THE INFORMATION REPORTED TO QUANTA, THE BLOOD LOSS FROM THE DIALYSIS MACHINE WAS REPORTED TO HAVE COME FROM THE BLOOD TUBE SET, SPECIFICALLY THE ANTI-COAGULANT LINE WAS REPORTED TO BE LEAKING AND THE CLAMP WAS REPORTED TO BE OPEN AND CAP MISSING ON THE ANTI-COAGULANT LINE. BASED ON THE FOLLOW UP WITH THE PATIENT, NO PRODUCT LOT NUMBER INFORMATION WAS AVAILABLE AND PRODUCT WAS DISCARDED AND WAS NOT AVAILABLE TO QUANTA FOR FURTHER INVESTIGATION. QUANTA IS ACTIVELY INVESTIGATING LEAKS FROM THE ANTICOAGULANT LINE THROUGH A CAPA PROCESS AND IN THE INTERIM QUANTA HAS INITIATED A FSCA (REFERENCE (B)(4)) BECAUSE IT HAS BEEN IDENTIFIED IN RARE OCCASIONS THAT THE STEPS DEFINED IN THE USER MANUAL AND IN THE WARNING ARE NOT APPROPRIATELY FOLLOWED BY THE USER WHICH COULD RESULT IN BLOOD LOSS WHICH COULD LEAD TO POTENTIAL SAFETY ISSUE IF THE BLOOD LOSS IS UNNOTICED. QUANTA WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS AND SHALL SUBMIT FURTHER NOTIFICATIONS SHOULD ANY NEW AND PERTINENT INFORMATION BECOME AVAILABLE. HUMAN FACTORS RISK REVIEW WAS PERFORMED AND THIS WAS IDENTIFIED AS A KNOWN RISK. THE USER MANUAL DIRECTS THE OPERATOR TO TIGHTEN THE ANTICOAGULANT LINE CAP AND CLOSE THE ANTICOAGULANT CLAMP AFTER PRIMING THE CIRCUIT. IN ADDITION TO THIS IT PROVIDES THE WARNING THAT LOOSE OR INCORRECTLY CONNECTED BLOOD LINES MAY RESULT IN BLOOD LEAKS AND THAT ALL CONNECTIONS SHOULD BE CHECKED TO ENSURE THAT THEY ARE TIGHT AND SECURE. HUMAN FACTORS RISK REVIEW WAS PERFORMED AND THIS WAS IDENTIFIED IN THE RISK FI LES AND APPROPRIATE MITIGATIONS ARE IN PLACE TO REDUCE THE RISK AS FAR AS POSSIBLE. A CAPA HAS BEEN INITIATED TO IDENTIFY AND DEFINE ANY ADDITIONAL MITIGATIONS TO BE ADDED TO FURTHER MITIGATE THE RISKS ASSOCIATED WITH THIS ISSUE. THIS INCIDENT IS COVERED UNDER FIELD SAFETY CORRECTIVE ACTION REPORTED TO MHRA ON JULY 07, 2023 - QUANTA REFERENCE FSCA-0723, MHRA FSCA REFERENCE(B)(4).

    Description of Event or Problem · 0

    DURING A SERVICE VISIT BY QUANTA ON JUNE 26, 2023,THE PATIENT REPORTED THAT DURING THEIR HEMODIALYSIS TREATMENT ON (B)(6) 2023, THEY SUFFERED A BLOODLOSS WHILE ON DIALYSIS. WHEN ASKED FOR THE DETAILS, OF THE BLOOD LOSS EVENT, THE PATIENT MENTIONED THAT THE PRODUCT WAS DISCARDED, AND NO LOT INFORMATION WAS AVAILABLE, AND THEY ESTIMATED LOSING ROUGHLY 500ML OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911114 DISPOSABLE BLOOD TUBE SET DISPOSABLE BLOOD TUBE SET FKY QUANTA DIALYSIS TECHNOLOGIES LTD SC-14358 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other