BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    MDR report key: 1755943 · Received July 14, 2010

    Report

    Report Number
    6000001-2010-01351
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON UPDATED INFORMATION FROM THE SERVICE DEPARTMENT AT BAXTER, THE REPORTED CONDITION WAS NOT CONFIRMED AND NOT DUPLICATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK COMING FROM THE LEFT SIDE OF THE CLOSED TUBE ALIQUOTTER (CTA) UNIT LOCATED IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. NO OPERATOR EXPOSURE WAS NOTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP HAS A CONSTANT ALARM THAT CANNOT BE SILENCED. THE EVENT OCCURRED DURING PATIENT THERAPY AND IT IS UNKNOWN IF PATIENT THERAPY WAS INTERRUPTED. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION (B)(4) CATEGORIZED AS REMEDIATED. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1