BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRYSYSTEM

    MDR report key: 32068 · Received April 18, 1996

    Report

    Report Number
    MW1008903
    Event Type
    Injury
    Date Received
    April 18, 1996
    Date of Event
    April 12, 1996
    Report Date
    April 17, 1996
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OCCLUSION SPRINGS SNAPPED ON THE BLOOD PUMP ROTOR ASSEMBLY OF THE HEMODIALYSIS MACHINE. DIALYSIS TECH NOTICED THAT ARTERIAL PRESSURE WAS NOT REGISTERING. PT WAS MOVED TO ANOTHER DIALYSIS MACHINE AND TREATMENT WAS RESUMED. BIOMEDICAL SPECIALIST INSPECTED UNIT AND FOUND BROKEN SPRINGS IN BLOOD PUMP ROTOR ASSEMBLY. SAME FAILURE HAS OCCURRED TWICE ON ANOTHER MACHINE IN THE SAME INTERMEDIATE DIALYSIS UNIT. MACHINE REPAIRED AND PLACED BACK INTO SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM HEMODIALYSIS MACHINE FII COBE RENAL CARE, INC. C3

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention