BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2240254 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23496
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION. THE EVENT DESCRIPTION INCORRECTLY LISTED THE PROBLEM AS A CONTRAST POTENTIOMETER ASSEMBLY, THIS HAS BEEN CHANGED TO THE CORRECT ISSUE OF DAMAGED CONTRAST CONTROL LABEL. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF MASTER COMPLAINT (B)(4). THE CAUSE WAS DETERMINED TO BE A DAMAGED CONTRAST CONTROL LABEL. TO CORRECT THE CONDITION, THE CONTRAST CONTROL LABEL WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    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

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A COLLEAGUE INFUSION PUMP REQUIRED THE REPLACEMENT OF A CONTRAST POTENTIOMETER ASSEMBLY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS INVOLVED A REMEDIATED COLLEAGUE INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1