BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARTRIDGE

    MDR report key: 16870194 · Received May 4, 2023

    Report

    Report Number
    9616240-2023-00004
    Event Type
    Death
    Date Received
    May 4, 2023
    Date of Event
    April 4, 2023
    Report Date
    June 7, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FJK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). G1: DEVICE MANUFACTURER ADDRESS 1 - NO. 10, JUNCHENG RD., EASTERN AREA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION ADDED TO B5. B5: AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE THIRD-PARTY CONNECTOR DISCONNECTED FROM THE CATHETER (PREVIOUSLY REPORTED THAT THE NOVALINE IS DISCONNECTED FROM THE THIRD-PARTY CONNECTOR). ADDITIONAL INFORMATION WAS ADDED TO H10. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PROVIDED PICTURE IDENTIFIED THE THIRD-PARTY CONNECTOR WAS DISCONNECTED FROM THE CATHETER INSTEAD OF ARTERIAL BLOOD LINE, INDICATING THIS ISSUE WAS NOT RELATED TO THE BLOOD LINE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARTERIAL BLOOD LINE DISCONNECTED FROM A THIRD-PARTY CONNECTOR DURING TREATMENT ON AN AK 98 MACHINE. WHILE THE PATIENT WAS CONNECTED FOR TREATMENT, THE PATIENT PASSED AWAY. THE ARTERIAL BLOOD LINE WAS FOUND TO BE DISCONNECTED AND AIR WAS OBSERVED IN THE LINE. THE ARTERIAL LINE CONNECTED TO THE PATIENT¿S CATHETER WAS ABRUPTLY HIT AND RESULTED IN THE DISCONNECTION. THE PATIENT WAS A SELF-TREATED HOME PATIENT, WHO HAD REPORTEDLY NOT FOLLOWED THE SAFETY PROCEDURES TO ENSURE THAT CONNECTIONS WERE SECURE. THE CAUSE OF DEATH WAS DETERMINED TO BE NATURAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620781 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Death AK 98 MACHINE.| TEGO CONNECTOR.| WRO300H.