BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2090335 · Received May 16, 2011

    Report

    Report Number
    6000001-2011-04098
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE CODE 310:422:558:4161 WAS CONFIRMED IN THE EVENT HISTORY. THE CAUSE WAS DETERMINED TO BE A SOFTWARE FAILURE. THE CONDITION DID NOT RECUR, NO FURTHER ACTION WAS REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP THAT WILL NOT TURN ON. THIS CONDITION WAS FOUND UPON POWER-UP OF THE DEVICE. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO INFORMATION ABOUT PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING REVIEW OF THE EVENT HISTORY BY BAXTER, IT WAS DETERMINED THAT THE FAILURE CODE 310:422:558:4161 OCCURRED DURING DELIVERY, CAUSING AN INTERRUPTION OF DELIVERY AND CAUSED THE DEVICE TO SHUT DOWN.

    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