BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1183684 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-01395
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 20, 2006
    Report Date
    December 20, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 12 2007. EVALUATION SUMMARY:THE CONDITION OF DEPLETED BATTERIES WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE PUMP'S BATTERIES HAD 12 BATTERY DISCHARGES BELOW THE ALARM THRESHOLD WHICH INDICATED THAT THE PUMP'S BATTERIES WERE DISCHARGED TO A POTENTIALLY DAMAGING LEVEL AND WERE THEREFORE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN DEPLETED BATTERIES. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1