BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023009 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-01254
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 1, 2006
    Report Date
    March 27, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF A LOW BATTERY WAS CONFIRMED. THE DEVICE WAS EVALUATED AT THE CUSTOMER'S SITE ON 03/27/2006. INSPECTION OF THE DEVICE IN THIS DATE FOUND THAT THE PUMP'S BATTERIES WERE DAMAGED 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

    A BAXTER ENGINEER REPORTED A PUMP WITH A LOW BATTERY. IT IS UNKNOWN WHEN THIS OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1