BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2152781 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10748
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 28, 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). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH ERROR CODE 810:11 WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A FAILURE IN THE PUMP'S AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB). THE AIL PCB WAS REPLACED TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WERE NO RESULTS OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    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