BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160145 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-00627
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 05 2007. EVALUATION SUMMARY:EVALUATION OCCURRED ON-SITE. FAILURE CODE 814:01 WAS CONFIRMED IN THE EVENT HISTORY. FAILURE CODE 814:01 OCCURS WHEN THE PUMP HEAD MODULE POWER SUPPLY IS TOO LOW. THIS CAN BE CAUSED WHEN THE PUMP IS LEFT IN THE BATTERY DEPLETED ALARM FOR AN EXTENDED PERIOD. INSPECTION OF THE PUMP DETERMINED THAT THE BATTERIES HAD 91 BATTERY DISCHARGES BELOW THE ALARM THRESHOLD WHICH INDICATED THAT THEY WERE DAMAGED, AND WERE THEREFORE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE DEPLETED BATERIES. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR FAILURE CODE 814:01. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    A BAXTER FIELD SERVICE ENGINEER REPORTED AN INFUSION PUMP WITH FAILURE CODE 814:01. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT 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. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1