BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2102379 · Received May 25, 2011

    Report

    Report Number
    6000001-2011-04611
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    December 13, 2010
    Report Date
    May 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS A FAULTY PUMPHEAD MODULE. THE PUMPHEAD MODULE GASKET HAS BEEN REPLACED. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, CATEGORIZED AS P1.5. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

    Description of Event or Problem · 1

    UPON REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, IT WAS FOUND THAT THIS DEVICE ENCOUNTERED FAILURE 808:02 DURING AN INFUSION ON (B)(6) 2010. SINCE THE ALARM INTERRUPTED DELIVERY, THIS IS A REPORTABLE MALFUNCTION. THIS COMPLAINT WILL ADDRESS THE SECOND ALARM ON (B)(6), 2010. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION 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