BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    MDR report key: 1181123 · Received October 2, 2008

    Report

    Report Number
    6000001-2007-01831
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    January 6, 2007
    Report Date
    January 6, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 17, 2007. EVALUATION SUMMARY:THE CONDITION OF DEPLETED BATTERIES WAS CONFIRMED. THE BATTERIES WERE REPLACED DUE TO POTENTIAL DAMAGE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE, THE BAXTER REPAIR TECHNICIAN NOTED DEPLETED BATTERIES. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1