BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2167749 · Received July 19, 2011

    Report

    Report Number
    6000001-2011-13030
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 589:317:1254 WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THERE HAVE BEEN NO REPAIRS.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 589:317:1254, WHICH MAY HAVE CAUSED AN INTERRUPTION OF DELIVERY. THE REPORTED CONDITION OCCURRED DURING SET-UP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 7:01:00. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1