BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2201136 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18232
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF BATTERY DAMAGE WAS NOT CONFIRMED DURING PRODUCT EVALUATION. ALSO, THE QUALITY ENGINEER HAS DETERMINED THE CAUSE TO BE NOT IDENTIFIED. SINCE NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION, NO REPAIR WAS NECESSARY OR PERFORMED FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "DAMAGED BATTERY".

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP FOR A DAMAGED BATTERY. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN. THERE IS NO FURTHER COMPLAINT INFORMATION 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