BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2143333 · Received June 29, 2011

    Report

    Report Number
    6000001-2011-09161
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. 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 EXCESSIVE ALARMS 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. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WHICH "ALARMS". THIS EVENT OCCURRED UPON POWER UP AND IT WAS "PICKED UP FROM CENTRAL SUPPLY". THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    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