BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL CXEPUMP V1.7

    MDR report key: 1993528 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01053
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE REPORTED CONDITION OF FAILURE CODE 812:02 WAS CONFIRMED THROUGH THE EVENT HISTORY BUT NOT DUPLICATED DUE TO A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 8.11.00 CATEGORIZED AS UNREMEDIATED. (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION. (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP IN WHICH THE DEVICE ALARMED FAILURE CODE 812:02 AND STOPPED. THE NURSE DISCONNECTED THE PUMP TO LOOK FOR A REPLACEMENT, BUT ANOTHER PUMP WAS NOT FOUND SO THE PATIENT WAS RE-CONNECTED TO THE PUMP, THE ALARM WAS CLEARED, AND THE PUMP WORKED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE SINGLE CHANNEL CXEPUMP V1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1