BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2141816 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08999
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM WAS CONFIRMED AND REPRODUCED DURING EVALUATION. THE CAUSE OF THE DAMAGED BATTERY WAS DUE TO USER ERROR. FROM THE EVENT HISTORY LOG IT WAS IDENTIFIED THAT THE PUMP WAS NOT CHARGED FOR 12 HOURS AFTER BATTERY LOW/BATTERY DEPLETED SET OCCURRED WHICH GOES AGAINST THE INSTRUCTIONS GIVEN IN THE MANUAL INDICATING A USER ERROR. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO FIX THE REPORTED CONDITION. THIS INVOLVED A COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. BAXTER'S INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. 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).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A BATTERY ISSUE. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED AND IF THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION IS CURRENTLY NOT KNOWN.

    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