BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2143179 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09148
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF ''SELECT'' BUTTON OF KEYPAD AT CHANNEL A WAS INOPERATIVE WAS CONFIRMED DUE TO FLUID INGRESS. THE KEYPAD WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT TO BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP IN WHICH THE ''SELECT'' BUTTON OF KEYPAD AT CHANNEL A WAS INOPERATIVE. THE REPORTED CONDITION OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.48.92.

    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