BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1190007 · Received October 8, 2008

    Report

    Report Number
    6000001-2007-02969
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 JAN 25, 2007. EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND THE DEPLETED BATTERY CONDITION AS CONFIRMED (10 DEPLETIONS BELOW ALARM THRESHOLD) DUE TO POTENTIALLY DAMAGED BATTERIES. BAXTER SERVICE TECHNICIAN 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. SERVICE WAS CONDUCTED ON-SITE.

    Description of Event or Problem · 1

    THE BAXTER FIELD SERVICE TECHNICIAN REPORTED A PUMP WITH DEPLETED BATTERIES FOUND DURING BIO-MED TESTING. DEVICE WAS SERVICED ON-SITE. 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