BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1914754 · Received December 3, 2010

    Report

    Report Number
    6000001-2010-05506
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE OF THIS EVENT WAS DETERMINED TO BE (B)(6) 2010. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DURING PREVIOUS SERVICE, THE PUMP HEAD MODULE WAS REPLACED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION AS FAILURE CODE 808:03. THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO REPAIRS WERE PERFORMED AT THIS TIME, AS THIS IS A BAXTER OWNED DEVICE. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OF OCCURRED ON (B)(6) 2010 AND NOT THE CUSTOMER REPORTED OCCURRENCE DATE OF (B)(6) 2010. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:03. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. BAXTER?S REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THE REPORTED CONDITION INTERRUPTED DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.09.90, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1