BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1801990 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02602
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, (B)(4) ASSOCIATED WITH THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF DEPLETED BATTERY WAS NOT CONFIRMED; THEREFORE, ASSIGNABLE CAUSE CANNOT BE DETERMINED. THIS DEVICE IS A STAY-IN UNIT AND WILL NOT BE REPAIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DEPLETED BATTERY. THIS REPORTED CONDITION WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING BAXTER QUALITY ENGINEERING REVIEW OF THE EVENT HISTORY ON JULY 28, 2010, IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1