BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AK 96 MACHINES

    MDR report key: 15549983 · Received October 6, 2022

    Report

    Report Number
    9616026-2022-00099
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 14, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS EVALUATED ON SITE BY A LOCAL HOSPITAL ENGINEER. DURING INSPECTION A LOOSENED TUBING THAT CONNECT THE MACHINE TO THE DIALYZER FILTER THAT CAUSED THE EXTERNAL LEAK WAS FOUND. THIS WAS REPAIRED AND AFTER RECONNECTING THE LOOSEN CONNECTOR, THE MACHINE WAS BACK TO NORMAL. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE (1) HOUR AFTER STARTING HEMODIALYSIS (HD) THERAPY USING AN AK 96 CONTROL UNIT, THE PATIENT EXPERIENCED FAINTING, VOMITING AND SHOCK. THE PATIENT WEIGHT WAS 51.1 KG G AFTER (ONE) 1 HOUR OF TREATMENT INDICATING AN EXCESSIVE FLUID REMOVAL OF 4.8L FROM THE START WEIGHT. THE PATIENT WAS TREATED WITH OXYGEN ADMINISTRATION, 2000 ML NORMAL SALINE, 5 MG DEXAMETHASONE, 20 MG OF GLUCOSE. THE PATIENT RECOVERED FROM THE EVENT. NO ALARM WAS GENERATED DURING THE TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2889220 AK 96 MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention POLYFLUX 14L DIALYZER| SANXIN A- CONCENTRATE| SANXIN BLOOD LINES