BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 156343 · Received March 14, 1998

    Report

    Report Number
    1713683-1998-00018
    Event Type
    Malfunction
    Date Received
    March 14, 1998
    Report Date
    February 19, 1998
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS BEING USED FOR PT TREATMENT AT TIME OF INCIDENT. THERE WERE NO KNOWN PHYSIOLOGICAL OR PROCEDURAL FACTORS INVOLVED. CPT/DTF HISTORY REVIEW REQUIRED AND DESCRIBED BELOW. REVIEW OF DTF HISTORY DOES NOT APPLY. REVIEW OF CPF HISTORY SHOWED NO RELATED DEFECTS SINCE MACHINE WAS RELEASED TO FIELD. SECONDARY SEARCH OF DTF HISTORY SHOWED NO RELATED DEFECTS. TEST RESULTS/ANALYSIS AND ANY DATA RECORDED: THE REPORTED CONDITION WAS NOT DUPLICATED. IT IS POSSIBLE, AT HIGH BLOOD FLOW RATES, FOR BUBBLE TO MOVE JUST PAST DETECTOR UNIT BEFORE CLAMP FULLY STOPS ALL BLOOD FLOW. THIS CAN GIVE USERS PERCEPTION THAT UABD DID NOT REACT APPROPRIATELY. HOWEVER, IT IS NOT CLEAR IF THIS IS WHAT THE FACILITY SAW, AND REPORTED IN THIS INCIDENT. FOLLOWING SAFETY ANALYSIS APPLIES: AIR IN BLOOD ALARM, AS DESCRIBED IN SECTION 5-11 OF THE CS3 OPERATOR'S MANUAL, RESULTS IN VISUAL AND STEADY AUDIBLE ALARM. VENOUS CLAMP OCCLUDES RETURN LINE AND STOPS BLOOD PUMP, ISOLATING PT FROM MACHINE. RESPONSE WOULD BE SAME EVEN OF UABD INDICATED THAT AIR WAS IN BLOOD WHEN IN FACT IT WAS NOT, THUS FALSE ALARM. IN EVENT OF NOT BEING ABLE TO RESET ALARM PT IS STILL SAFE BECAUSE VENOUS CLAMP IS STILL CLAMPED AND BLOOD PUMP IS STILL STOPPED. IN ADDITION BLOOD CAN BE RETURNED TO PT MANUALLY BY FOLLOWING MANUAL BLOOD RETURN PROCEDURE IN OPERATOR'S MANUAL. FOLLOW-UP ACTION: ABOVE TESTING INDICATES THAT THIS COMPONENT/ASSEMBLY MET MFG SPECIFICATIONS. FAILURE MODE DESCRIBED IN THIS COMPLAINT IS ADDRESSED BY CORRECTIVE ACTION ANALYSIS NUMBER(S): FAR#950033.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AIR IN BLOOD WITH NO AIR IN BLOOD ALARM. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    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 Other