BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    MDR report key: 20238419 · Received September 17, 2024

    Report

    Report Number
    3015085713-2024-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ASSET MEDIKAL TASARIM SAN. TIC. A.S.
    Product Code
    FPA
    UDI-DI
    08699443580044
    PMA / PMN Number
    K222889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE USER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. THE DEVICE HISTORY RECORDS DID NOT SHOW ANY CONCERNS REGARDING THE DISCONNECTION. PRODUCT WAS DESIGNED & TESTED ACC. TO ISO 80369-7.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE USER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. LOT WAS NOT PROVIDED. THE DEVICE HISTORY RECORDS COULD NOT BE INVESTIGATED. PRODUCT WAS DESIGNED & TESTED ACC. TO ISO 80369-7.

    Description of Event or Problem · 0

    SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREADING THE VALVE TO SYRINGES OR BLOOD LINES, THE NURSE BELIEVES THAT THE VALVE DID NOT CONNECT PROPERLY TO THE THREADS OF THE BLOOD LINE, WHICH RESULTED IN THE DISCONNECTION. THE DIFFICULTY IN VALVE ATTACHMENT WAS NOT A MAJOR CAUSE FOR CONCERN UNTIL THE VALVE BECAME DISCONNECTED FOR THE BLOOD LINE. THE PRODUCT WAS NOT RETAINED FOR RETURN TO THE MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT'S BLOOD LINE BECAME DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT WAS RECEIVING A DIALYSIS TREATMENT, WHICH RESULTED IN BLOOD LOSS. THE PATIENT'S HEMOGLOBIN WAS 9.9 ON (B)(6) 2024 PRIOR TO THE EVENT, AND THE PATIENT WAS ON MIRCERA 50 MCG EVERY 4 WEEKS. ON (B)(6) 2024 THE DAY AFTER THE DISCONNECTION, THE PATIENT'S HEMOGLOBIN DROPPED TO 7.8. THIS REQUIRED THE MIRCERA DOSE TO BE INCREASED TO 100 MCG EVERY 2 WEEKS. THIS WAS ORIGINALLY REPORTED ON 8/6/2024, HOWEVER, SPECIFIC INFORMATION FOR THIS PATIENT WAS NOT PROVIDED. THIS IS THE ONLY ONE OF THE 6 THAT WAS PROVIDED WHO SUSTAINED HARM. HOWEVER, THE POTENTIAL FOR SERIOUS INJURY OR EVEN DEATH FROM EXSANGUINATION IS GREAT IF THERE IS A DISCONNECTION DURING THE DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808725 FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA ASSET MEDIKAL TASARIM SAN. TIC. A.S. A1010H-S UNKNOWN 08699443580044

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention