BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240583 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04060
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 15, 2007
    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

    EVALUATION SUMMARY: THE PUMP WAS EVALUATED ON SITE. INSPECTION OF THE DEVICE REVEALED DEPLETED/POTENTIALLY DAMAGED BATTERIES. THE BATTERIES WERE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH DEPLETED BATTERIES. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT'S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE.

    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