BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2170507 · Received July 21, 2011

    Report

    Report Number
    6000001-2011-13257
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER RETURNED A COLLEAGUE INFUSION PUMP TO BAXTER WITH A MALFUNCTION OF DAMAGED BATTERY. THE REPORTED PROBLEM WAS NEITHER CONFIRMED NOR REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THERE HAVE BEEN PREVIOUS REPORTED PROBLEMS WITH THIS DEVICE THAT ARE THE SAME AS OR SIMILAR TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD A DAMAGED BATTERY. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED UPON POWER ON IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. 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