BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2143198 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09149
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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. THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN UPSTREAM OCCLUSION ALARM WAS CONFIRMED DURING PRODUCT EVALUATION, BUT NOT DUPLICATED. THE ROOT CAUSE OF THIS CONDITION WAS DUE TO A FAULTY PUMPHEAD MODULE. THE PUMPHEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED

    Description of Event or Problem · 1

    THIS IS A COLLEAGUE PUMP RETURNED TO BAXTER TECHNICAL SERVICES WHERE UPSTREAM OCCLUSION WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT. THIS COULD HAVE BEEN A FALSE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1