BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2104289 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04817
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. 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 AND DUPLICATED. THE ASSIGNABLE CAUSE WAS AN PUMPHEAD MODULE (PMU) SHUTTLE MOTOR. THE PMU SHUTTLE MOTOR HAS BEEN REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT A COLLEAGUE INFUSION PUMP IN WHICH FAILURE CODE 812:02 OCCURRED UPON POWER ON. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING BAXTER'S REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT FAILURE CODE 812:02 OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THIS DEVICE IS A P1.7 COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 7.01.00.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1