BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 76845 · Received March 19, 1997

    Report

    Report Number
    1713683-1997-00195
    Event Type
    Injury
    Date Received
    March 19, 1997
    Report Date
    February 19, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT IN QUESTION INVOLVED THREE PTS DIALYZED ON ONE MACHINE ON OR ABOUT FEBRUARY 17-18, 1997. THE INCIDENT WAS REPORTED TO GAMBRO HEALTHCARE ON 2/19/97. CO IN TURN REPORTED IT TO GAMBRO HEALTHCARE QA ON 2/20/97. ALL THREE PTS EXPERIENCED SYMPTOMS CONSISTENT WITH HYPOATREMIA DEVELOPING DURING THEIR DIALYSIS TREATMENT. PT WAS DIALYZED ON THIS MACHINE ON 2/17 IN EVENING AND EXPERIENCED NAUSEA, CRAMPING AND CHILLS. HOWEVER, THIS PT DIALYZED ON THE MACHINE FOR ONLY TWO HOURS BEFORE TREATMENT TERMINATION, AND DID NOT NEED HOSPITALIZATION. SECOND PT TREATMENT WAS THE FIRST ON 2/18 ON THE SAME MACHINE. THIS PT WAS DISCONNECTED AFTER ABOUT 2 HOURS OF TREATMENT, HAD A POST-TREATMENT BLOOD SODIUM OF 129, HAD SYMPTOMS OF DELIRIUM DURING THE TREATMENT, AND WAS HOSPITALIZED. HE HAS SINCE RECOVERED. THIRD PT WAS SECOND PT TREATED ON 2/18 ON THE SAME MACHINE. THIS PT WAS DISCONNECTED AFTER ABOUT 2 HOURS OF TREATMENT, HAD A POST-TREATMENT BLOOD SODIUM OF 119, HAD SYMPTOMS OF DELIRIUM DURING THE TREATMENT, AND WAS HOSPITALIZED. THIS PT ALSO RECOVERED. THE ABOVE TREATMENTS WERE THE FIRT FOLLOWING A PREVENTATIVE MAINTENANCE BY A FACILITY TECH. FACILITY CLAMES THAT NO ADJUSTMENTS TO THE MACHINE WERE MADE. THE FACILITY FURTHER CLAMIS THAT THE BICARBONATE AND FINAL CONDUCTIVITIES (AND THEREFORE BICARBONATE AND FINAL SODIUM) LEVELS WERE LOW, YET MACHINE OPERATED WITHOUT ALARMS. FACILITY ALSO ALLEGS THAT THEY CHECKED THE CONDUCTIVITY OF DIALYSATE BEFORE EACH DIALYSIS USING AN INDEPENDENT CONDUCTIVITY METER AND FOUND CONDUCTIVITIES TO BE APPROPRIATE. DTF HISTORY DOES NOT APPLY. THERE WERE NO RELATED COMPLAINTS OTHER THAN THE TWO OTHER PT INCIDENTS REPORTED AS PART OF THE ORIGINAL COMPLAINT.

    Description of Event or Problem · 1

    PT BECAME DALIRIOUS DURING A DIALYSIS TREATMENT. LAB RESULTS SHOWED LOW SODIUM LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT FII GAMBRO HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R