BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1170867 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-06365
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    October 10, 2006
    Report Date
    November 6, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MAY 29 2007. EVALUATION SUMMARY: THE REPORTED CONDITION OF UNDERDELIVERY WAS CONFIRMED BY THE FACILITY'S BIOMED. THE PUMP HEAD MECHANISM WAS RETURNED TO BAXTER FOR EVALUATION. BAXTER'S PERFORMANCE ANALYSIS LAB (PAL) HAD PREVIOUSLY TESTED AND CONFIRMED A NUMBER OF PUMP HEADS FROM THIS FACILITY FOR THE SAME REPORTED PROBLEM OF UNDERDELIVERY. SINCE THIS IS A KNOWN ISSUE, NO FURTHER TESTING WAS DONE. THE CUSTOMER WAS PROVIDED WITH NEW PUMPHEADS. 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

    THE FACILITY REPORTED A PUMP IN WHICH AN ACCURACY TEST WAS RUN RESULTING IN AN UNDERDELIVERY. THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. 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