BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2150375 · Received July 6, 2011

    Report

    Report Number
    6000001-2011-10452
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-08/04/10-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING 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 DAMAGED BATTERY WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL. QUALITY ENGINEERING HAS REVIEWED THE SERVICE EVALUATION AND HAS DETERMINED THAT A FAILURE CODE 810:11, WHICH WAS THE LAST FAILURE TO OCCUR PRIOR TO THE DEVICE BEING SENT FOR EVALUATION, WILL BE CHOSEN FOR THE AS DETERMINED PROBLEM. THE CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. AIR IN LINE CALIBRATION WAS PERFORMED DURING INITIAL TESTING OF THE DEVICE; HOWEVER, NO REPAIRS WERE MADE TO CORRECT THE REPORTED CONDITION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED BUT WAS REPORTED TO HAVE OCCURRED IN THE GENERAL PATIENT WARD. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1