BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2200072 · Received August 10, 2011

    Report

    Report Number
    6000001-2011-17890
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 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
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY INDICATOR SEEMS INACCURATE WAS NOT CONFIRMED OR REPRODUCED DURING PRODUCT EVALUATION. HOWEVER QUALITY ENGINEERING IDENTIFIED FAILURE CODE 199:117:284:0000 TO BE THE DETERMINED CONDITION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO CORRECT THIS CONDITION. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. HOWEVER DURING PREVIOUS SERVICE THE MAIN BATTERIES AND HARNESS WERE REPLACED.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A REPORTED CONDITION OF "BATTERY INDICATOR SEEMS INACCURATE." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED IN THE GENERAL PATIENT WARD. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INVOLVEMENT, PATIENT INJURY, OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. 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