BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008H

    MDR report key: 887631 · Received July 25, 2007

    Report

    Report Number
    887631
    Event Type
    Death
    Date Received
    July 25, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 24, 2007
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS ONE OF TWO PTS W/LOW SODIUM BALANCE AND VOLUME OVERLOAD AFTER DIALYSIS TX ON SPECIFIC DIALYZER. PT CODED IN DIALYSIS REVIVED. PT DIALYZED TWO ADDITIONAL TIMES ON DIFFERENT MACHINES. BUT CONTINUED TO DECLINE AND EXPIRED 2-DAYS LATER. TESTING OF MACHINE POST-EVENT REVEALS CONDUCTIVITY CALIBRATION ANOMALY (INTERNAL READOUT: 13.3, EXTERNAL METER: 9.6) AND ACID PUMP PUMPING AT LOW VOLUME (91, S/B 150 157). PUMP DID NOT ALARM DURING TESTING PROCEDURE. PUMP SEALS/SPRINGS CORRODED, PUMP REPLACED, PUMP SENT TO MFG FOR FAILURE ANALYSIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008H HEMODIALYSIS SYSTEM FII FRESENIUS USA 2008H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death TREATED W/COVER STENT| PTA W/STENT OF LF LEG| TOTAL CONTRAST 230ML| TOTAL FLOURO: 189| PERF OF ILIAC INTRA-OP