BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2163046 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12121
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP THAT EXPERIENCED A DEPLETED BATTERY WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED BATTERIES RESULTING FROM USER ERROR. THIS CONDITION WAS RESOLVED ON-SITE BY REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DEPLETED BATTERY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    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