BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2150316 · Received July 6, 2011

    Report

    Report Number
    6000001-2011-10445
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE IS AVAILABLE. SHOULD THE PUMP BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 812:02 WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL; HOWEVER, QUALITY ENGINEERING HAS REVIEWED THE SERVICE EVALUATION AND DISCOVERED THAT FAILURE CODE 812:02 WAS FOUND IN THE EVENT HISTORY ON CHANNEL A AND CONFIRMS THE REPORTED CONDITION. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE A DEFECTIVE PUMP HEAD MODULE ON CHANNEL A. THE CHANNEL A PUMP HEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP THAT EXPERIENCED FAILURE CODE 812:02. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO INFORMATION REGARDING PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    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