BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023055 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-02794
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    August 1, 2006
    Report Date
    August 17, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ON JAN 25 2007. EVALUATION SUMMARY:THE DEVICE WAS EVALUATED AT A BAXTER SERVICE CENTER. THE REPORTED CONDITION OF FAILURE CODE 814:01 WAS CONFIRMED. THE BATTERIES WERE FOUND DEPLETED TO A POTENTIALLY DAMAGING LEVEL WHICH CAUSED THE FAILURE TO OCCUR. THE BATTERIES WERE REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL. 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

    CUSTOMER REPORTED A FAILURE CODE 814. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. CUSTOMER DID NOT HAVE INFORMATION WHETHER INCIDENT OCCURRED DURING PATIENT INFUSION. ALTHOUGH BAXTER REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING INFORMATION. NO ADDITIONAL CONTACT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1