BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2230540 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21989
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 25, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS ASSIGNED TO USE/USER ERROR. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. ADDITIONAL INFORMATION: SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. BAXTER'S INVESTIGATION IS STILL IN PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THIS INVOLVED A REMEDIATED COLLEAGUE 2006 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1