BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2142971 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09144
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 2, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT USER ERROR HAS CONTRIBUTED TO THIS EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. THE CONDITION OF BATTERY ISSUE WAS CONFIRMED THROUGH THE EVENT HISTORY DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS WERE 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

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    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