BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1170985 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-02772
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 18, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 24, 2007. EVALUATION SUMMARY:THE DEVICE EVALUATION WAS COMPLETED AND DURING SERVICE TESTING, THE DEPLETED BATTERY CONDITION REVEALED DAMAGED BATTERIES, RESULTING IN THE GENERATION OF CONFIRMED FAILURE CODE 570:320:844:0000 (WHEN TURNED ON). SERVICE INSTALLED NEW BATTERIES AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALED SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT AND THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH DEPLETED BATTERIES. INFORMATION WAS NOT PROVIDED REGARDING WHETHER THE EVENT OCCURRED DURING PATIENT USE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1