BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-06 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 10982697 · Received December 10, 2020

    Report

    Report Number
    8031561-2020-00003
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    August 26, 2014
    Report Date
    December 10, 2020
    Manufacturer
    NIKKISO CO.,LTD
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ERROR CODE TFD141 ISSUED BY NIKKISO DBB-06 DIALYSIS MACHINE (MACHINE BLOOD PUMP STOPPED). BLOOD PUMP RESTARTED BY ATTENDING NURSE BY PRESSING ALARM RESET. PATIENT BLOOD RETURNED THROUGH CIRCUIT BACK TO PATIENT. 300MLS OF SALINE ADMINISTERED TO PATIENT. PATIENT DISCONNECTED FROM MACHINE. PATIENT DID NOT DISPLAY ANY ADVERSE OUTCOMES FROM THE EVENT. NIKKISO DIALYSIS MACHINE REMOVED TO WORKSHOP FOR EVALUATION AND REPAIR. BAXTER TECHNICAL SERVICE NOTIFIED. NIKKISO DBB-06 DIALYSIS MACHINE TFD141 ALARM. IN THIS INSTANCE THE PATIENT WAS DISCONNECTED FROM THE MACHINE WITH NO ILL EFFECT. THE MACHINE HAS REMOVED FROM THE TREATMENT FLOOR AWAITING SERVICE FROM BAXTER TECHNICAL SERVICE. (B)(4) WILL ATTEND TO THE MACHINE ON MONDAY ON HIS RETURN FROM LEAVE. THE DIALYSIS UNIT (B)(6) HAS THREE SPARE MACHINES SHE CAN USE IN THE INTERIM PERIOD IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451436 DBB-06 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER KDI NIKKISO CO.,LTD DBB-06 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BLOOD TUBING LINE : AV06JE-PDIALYZER