BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2162375 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11890
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 17, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH "CHANNEL A CANNOT LOAD TUBING SET" WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A DEFECTIVE CHANNEL A PUMPHEAD MODULE. THE CHANNEL A PUMPHEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.92. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT TO BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP IN WHICH THE CHANNEL A CANNOT LOAD TUBING SET, POSSIBLY CAUSED BY A MISALIGNED PUMP HEAD OR DAMAGED PUMP HEAD MODULE. THIS CONDITION COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. THE REPORTED CONDITION OCCURRED BEFORE USE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE FOR THIS DEVICE IS CURRENTLY NOT KNOWN. 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