BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2192281 · Received August 4, 2011

    Report

    Report Number
    6000001-2011-16693
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY NOT HOLDING CHARGE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED BATTERIES RESULTING FROM USER ERROR. APPROPRIATE ACTION WAS TAKEN TO CORRECT THE REPORTED PROBLEM BY REPLACING THE MAIN BATTERIES AND HARNESS. ADDITIONAL INFORMATION: THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF A BATTERY NOT HOLDING A CHARGE. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED, HOWEVER IT WAS KNOWN TO HAVE OCCURRED IN THE INTENSIVE CARE UNIT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. 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