BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS 2008 BSS

    MDR report key: 14307 · Received March 18, 1994

    Report

    Report Number
    2243621-1994-00015
    Event Type
    Other
    Date Received
    March 18, 1994
    Date of Event
    November 22, 1993
    Report Date
    January 26, 1994
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    FLC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DENIED COMPLAINTS PRE-DIALYSIS. TEMP. 97.6, BP 120/70 WEIGHT 138 LBS,, GAINED 2 LBS. DIALYSIIS WAS INITIATED IN THE USUAL MANNER AT 300 BLOOD FLOW RATE. 470 ULTRAAAFILTRATION GAAOL 1400CC. 2HRS 5 MINS INTO DIALYSIS PT'S BP WAS 90/60. PT WAS LETHARGICAND 200CC NORMAL SALINE WAS GIVEN. BP REMAINED LOW - 80/60-90/60 AND DIALYSIS WA TERMINATED AT 2HRS 35 MINS BECAUSE BLOOD PRESSURE DID NOT IMPROVE IN SPITE OF AN ADDITIONAL 550CC SALINE. PT ALSO REPORTED CRAMPING. POST DIALYSIS TEMP. 98.0, BP 120/70, POST WEIGHT 135 - LOSS 3 LBS. THE PT WAS ASYMPTOMATIC POST TREATMENT AND WAS SENT HOME. THIS WAS THE SECOND INCIDENT ON THIS MACHINE THAT INVOLVED THIS PT. IT WAS THE THIRD INCIDENT ON THE MACHINE SINCE 11/15/93. THE CHIEEEF TECHNICIAN REMOVED THE MACHINE FROM USE. THE U.F. RATE WAS RECALIBRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008 BSS BEDSIDEE STATIOIN DIALYSIS MACHINE FLC FRESENIUS USA, INC. 2008 BSS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other FRESENIUS F8 DIALYZER 16TH USE| BLOODLINE UNKNOWN