BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2211388 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18873
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED AND REPRODUCED DURING ON-SITE PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS DEPLETED MAIN BATTERIES AS A RESULT OF USE ERROR. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A SERVICE HISTORY REVIEW REVEALED THE DEVICE HAD PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. DURING PREVIOUS SERVICE THE BATTERIES AND HARNESS WERE REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. 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