BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023130 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00575
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 8, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 810:11 COULD NOT BE CONFIRMED ON SITE AT THE CUSTOMER LOCATION BY THE FIELD SERVICE ENGINEER. TYPICALLY, THIS FAIL CODE IS RELATED TO THE AIR IN LINE PRINTED CIRCUIT BOARD. THIS ISSUE HAS BEEN ADDRESSED PER BAXTER'S FIELD CORRECTION ACTION LETTER. SERVICE OF THE DEVICE WAS CONDUCTED ON-SITE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED FAILURE CODE 810:11. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING A PATIENT INFUSION. THE DEVICE WAS SERVICED ON SITE AT THE CUSTOMER'S LOCATION BY A FIELD SERVICE ENGINEER. THE FACILITY REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. ADDITIONAL CONTACT INFORMATION WAS NOT AVAILABLE. NO OTHER INFORMATION IS KNOWN.

    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