BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2201003 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18221
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THE DEVICE HAS NOT BEEN PREVIOUSLY SENT IN FOR THE REPORTED CONDITION. HOWEVER, DURING PREVIOUS SERVICES, THE BATTERIES AND BATTERY HARNESS HAVE BEEN REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF DAMAGED BATTERY ALARM WAS CONFIRMED AND REPRODUCED. THE BAXTER PERSONNEL HAVE DETERMINED THAT THIS CONDITION IS DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO RESOLVE THE REPORTED PROBLEM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF DAMAGED BATTERY ALARM. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. 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