BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2171874 · Received July 22, 2011

    Report

    Report Number
    6000001-2011-13425
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN ERROR 313 WAS CONFIRMED BUT NOT REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. NO REPAIRS HAVE BEEN PERFORMED DUE TO THE CUSTOMER?S REFUSAL OF ESTIMATE, NO FURTHER CORRECTION WAS MADE CONCERNING THIS EVENT AND THE PUMP WAS RETURNED UNREPAIRED. ADDITIONAL INFORMATION: THIS INVOLVED AN UNREMEDIATED INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.01.00.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MED WATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 313, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION IS CURRENTLY NOT KNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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