BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SC+ HAEMODIALYSIS DEVICE

    MDR report key: 18008646 · Received October 26, 2023

    Report

    Report Number
    3013536188-2023-00009
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    July 1, 2022
    Report Date
    October 26, 2023
    Manufacturer
    QUANTA DIALYSIS TECHNOLOGIES LTD
    Product Code
    KDI
    PMA / PMN Number
    K210661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AGAIN TO FDA DUE TO RECEIVING EMAIL REPORT FROM FDA INDICATING ORIGINAL REPORT HAD INVALID MFR NUMBER. THE ORIGINAL REPORT NUMBER WAS 0000000-2022-09000. THE INFORMATION PROVIDED IN THIS REPORT IS SIMILAR TO REPORT 0000000-2022-09000. (B)(4). FOLLOWING RECEIPT OF THE INCIDENT REPORT FROM THE HOSPITAL, QUANTA PERFORMED A DETAILED REVIEW OF THE MACHINE LOG ASSOCIATED WITH THE TREATMENT. THE REVIEW HAS SHOWN THAT THE SC+ WAS OPERATING AS INTENDED AND NO FAULTS WITH THE DEVICE WERE IDENTIFIED. THEREFORE, THE RESULTS OF OUR INVESTIGATION HAVE CONCLUDED THAT THE ADVERSE EVENT WAS CAUSED BY USER ERROR AND THE SC+ SHOWS NO SIGN OF FAULT. THE CONCLUSION THAT THE EVENT RESULTED FROM USER ERROR IS SUPPORTED BY THE FEEDBACK PROVIDED BY THE HOSPITAL NURSE WHICH STATED THAT THE PATIENT HAD REVERSED HER VENOUS AND ARTERIAL ACCESS ON THE CENTRAL VENOUS CATHETER. LOT RELEASE RECORDS AND DHR RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. IN ADDITION, AS THIS INCIDENT TOOK PLACE IN UNITED KINGDOM, QUANTA REPORTED THE INCIDENT TO MHRA. TRENDING WILL BE MONITORED FOR THIS AND OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    (B)(6) HOSPITAL REPORTED A USER ERROR HAD OCCURRED AT THE END OF A DIALYSIS TREATMENT: AT THE END OF A HAEMODIALYSIS TREATMENT SESSION, A PATIENT IS REQUIRED TO RETURN THE BLOOD THAT REMAINS IN THE EXTRACORPOREAL CIRCUIT BACK INTO THE BODY. THIS IS NORMALLY ACHIEVED BY CONNECTING THE ARTERIAL LINE TO A SALINE BAG AND FLUSHING THE LINE WITH SALINE SOLUTION. HOWEVER, IN THE REPORTED INCIDENT, THE SELF-CARE PATIENT INCORRECTLY CONNECTED THEIR VENOUS LINE TO THE SALINE BAG INSTEAD OF THE ARTERIAL LINE. THE PATIENT ATTEMPTED TO RETURN THE BLOOD BY STARTING THE BLOOD PUMP WHICH RESULTED IN BLOOD BEING PUSHED INTO THE SALINE BAG INSTEAD OF SALINE SOLUTION BEING PUSHED INTO THE BLOOD CIRCUIT. A HEMODIALYSIS NURSE SPOTTED THE USE ERROR AND RECTIFIED THE SITUATION BY CORRECTLY CONNECTING THE LINES AND RETURNING THE BLOOD BACK TO THE PATIENT. THE HOSPITAL REPORTED THAT THE PATIENT INITIALLY EXPERIENCED HYPOVOLEMIC SYMPTOMS (BLURRY VISION AND DIZZINESS) WHICH THEN STOPPED AFTER THE BLOOD WAS SUCCESSFULLY RETURNED TO THE PATIENT. NO MEDICATION WAS ADMINISTERED AND NO BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140765 SC+ HAEMODIALYSIS DEVICE SC+ KDI QUANTA DIALYSIS TECHNOLOGIES LTD SC-12410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other