BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAKE-WILLOCK SYSTEM 1000

    MDR report key: 101566 · Received June 26, 1997

    Report

    Report Number
    101566
    Event Type
    Injury
    Date Received
    June 26, 1997
    Date of Event
    May 22, 1997
    Report Date
    June 2, 1997
    Manufacturer
    ALTHIN
    Product Code
    FKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT STARTED ON DIALYSIS AT 0625; ON ALTHIN 1000 #31. AT 0655 PT NOT RESPONSIVE. NOTED TO HAVE NO RESPIRATIONS. HEAD LOWERED AND FEET ELEVATED; NORMAL SALINE GIVEN. O2 STARTED AT 24NC. PT PLACED ON FLOOR. B/P 180/80. EKG MONITOR CONNECTED, NORMAL SINUS. PT'S BLOOD RETURNED. RESPIRATION RESUMED. ATTENDING PHYSICIAN AND MEDICAL DIRECTOR NOTIFIED. EXAMINED BY ATTENDING PHYSICIAN. NOTED GOAL SET AT 2.7 KG. NOTED UFR WAS 1.97 AFTER FIRST 30 MIN OF TREATMENT. TREATMENT RESUMED & COMPLETED ON BAXTER MACHINE. AMBULATORY FROM UNIT. WT 55 KG. B/P NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAKE-WILLOCK SYSTEM 1000 DIALYSIS DELIVERY SYSTEM FKP ALTHIN 1000 ALTHIN SYS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization NH