BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAKE WILLOCK SYSTEM 1000

    MDR report key: 20529 · Received December 2, 1994

    Report

    Report Number
    2243621-1994-00494
    Event Type
    Other
    Date Received
    December 2, 1994
    Date of Event
    October 31, 1994
    Report Date
    November 3, 1994
    Manufacturer
    ALTHIN MEDICAL INC.
    Product Code
    FJI
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE RECIRCULATION PERIOD PRE-TREATMENT, THE DIALYSATE LINE DETACHED FROM THE HANSON CONNECTOR CONNECTED TO THE DIALYSATE PART ON THE DIALYZER. THE LINE WAS REPLACED. PRE-TREATMENT MACHINE CHECKS WERE DONE. THE PT'S TREATMENT WAS INITIATED AND HE WAS SET TO LOSE 4.8 KGS. IN FOUR HRS. NONE HR INTO THE TREATMENNTHE COMPLAINED OF NOT FEELING WELL AND WAS GIVEN NORMAL SALINE. ONE HALF HR LATER THE PT COMPLAED OF CRAMPS AND WAS GIVEN HYPERTONIC SALINE. HE THEN VOMITED AND LOSS CONSCIOUSNESS. HE WAS GIVEN 600 CC NS AND HIS CONDITION STABILIZED. THE TREATMENT WAS DISCONTINUED ND THET WAS WEIGHTED. HE LOST 4.4 KG IN TWO HRS. THE PHYSICIAN WAS NOTIFIED. THE TFR RECORDED BY THE MAACHINE WAS 2.2 KG. THE PT WAS DISCHARRGED TO HOME IN STABLE CONDITION. THE MACHINE WAS PULLED OFF THE TREATMENT FLOOR AND LOXCAND LOCKED. THE AREA TECHNICAL MANAGER WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAKE WILLOCK SYSTEM 1000 HEMODIALYSIS MACHINE FJI ALTHIN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other TERUMO T-175 DIALYZER