BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS 2008 BSS

    MDR report key: 14306 · Received March 18, 1994

    Report

    Report Number
    2243621-1994-00013
    Event Type
    Other
    Date Received
    March 18, 1994
    Date of Event
    November 15, 1993
    Report Date
    January 25, 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 HAD NO COMPLAINTS PRE DIALYSIS, BLOOD PRESSURE 140/80, TEMP. 98.7, 5 LBS WEIGHT GAIN. DIALYSIS WAS INITIATED IN THE USUAL MANNER AT 300CC BLOOD-FLOW RATE. 810CC ULTRAFILTRATION RATE. AT ONE HR AND 35 MIN INTO TREATMENT PT WAS GIVEN 5CC OF HYPERTONIC SALINE IV - BP 110/80 - ULTRAFILTRATION RATE 790CC 2 HRS 35 MINS INTO TREATMENT THE PT REQUESTED SALINE ADMINISTRATION BECAUSE SHE WAS FEELING POORLY. 200 CC SALINE WAS GIVEN AND REPEATED AT 2 HRS AND 50 MINS FOR SAME COMPLAINT. BP WAS 120/80 ULTRAFILTRATION RATE WAS TURNED OFF AAT PT'S REQUEST 3 HRS 20 MINS INTO TREATMENT BECAUSE PT REPORTED NOT FEEELING WELL - BP 120/80. TREATMENT WAS DISCONTINUED AT 3.5 HRS AS SCHEDULED POST TREATMENT BLOOD PRESSURE WAS 140/80 SITTING, 100/80 STANDING. THE PT LOST 7LBS DURING TREATMMENT (PRE-WEIGHT 132 - POST WEIGHT 125) TARGET GOAL FOR ULTRAFILTRAION CALCULATED AT 2750 AND SET ON THE MACHINE. ULTRFILTRATION AMOUNT RECORDED AT THE END OF DIALYSIS WAS 2503CC. THE PT WAS SENT HOME AFTER TREATMENT WITHOUT COMPLAINTS. THE MACHINE WAS REMOVED FROM SERVICE ON 11/17/93 BECAUSE OF DIALYSATE FLOW. UF PUMP VOLUME, TMP CALIBRATION AND MACHINE SEEEELF TEST AND PRESSSURE HOLDING TEST WERE PERFORMED BY THE CHIEF TECHNICIAN. ALL CALIBRATIONS AND TEST WERE SATISFACTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other KNOWN| FRESENIUS F8 DIALYZER REUSE #6 BLOODLINES NOT