BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    MDR report key: 1181124 · Received October 2, 2008

    Report

    Report Number
    6000001-2007-01828
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 19, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    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: DURING PRODUCT EVALUATION THE CONDITION OF FALSE AIR IN LINE COULD NOT BE CONFIRMED OR DUPLICATED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. NO ACTION WAS NECESSARY. THE ISSUE IS BEING INVESTIGATED UNDER.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSION PUMP WITH A CONSTANT AIR IN LINE ALARM. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. THE HOSPITAL REPRESENTATIVE DID NOT HAVE INFORMATION REGARDING WHETHER THERE HAVE BEEN ANY REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. 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