BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2193405 · Received August 5, 2011

    Report

    Report Number
    6000001-2011-16787
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THERE HAVE BEEN PREVIOUS REPORTED PROBLEMS WITH THIS DEVICE THAT ARE THE SAME AS OR SIMILAR TO THE REPORTED CONDITION. QUALITY ENGINEER HAS DETERMINED THAT THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY RESULTED FROM USER ERROR. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF DAMAGED BATTERY WAS CONFIRMED AND REPRODUCED. THE BAXTER PERSONNEL HAVE DETERMINED THAT THIS CONDITION IS DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO RESOLVE THE REPORTED PROBLEM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF DAMAGED BATTERY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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