BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2170692 · Received July 21, 2011

    Report

    Report Number
    6000001-2011-13289
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    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). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY WAS NOT CONFIRMED NOR DUPLICATED DURING PRODUCT EVALUATION. DELIVERY ACCURACY TESTS WERE PERFORMED AND FOUND THE PUMP TO BE DELIVERING WITHIN SPECIFICATIONS. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THE REPORTED CONDITION AND NO REPAIR WAS NECESSARY. 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. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION OF A DAMAGED BATTERY. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1