BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL MONOCHROME PUMP ENGLISH V1.7

    MDR report key: 2022879 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01965
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 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

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL 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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A CONSTANT AIR IN LINE ALARM WAS CONFIRMED AND DUPLICATED BY BAXTER PERSONNEL. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A PUMP MODULE UNIT (PMU) AIR IN LINE (AIL) SENSOR. THE PMU AIL SENSOR WAS REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THE USER INTERFACE MODULE SOFTWARE VERSION IS 7.01.00. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP IN WHICH THERE IS A CONSTANT AIR IN LINE ALARM FOUND DURING ROUTINE PREPARATION FOR USE TEST BUT THERE IS NO AIR PRESENT. THERE IS NO PATIENT INVOLVEMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1