BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2100879 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04460
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE CODE 812:05 WAS CONFIRMED BUT NOT DUPLICATED. FAILURE CODE 812:05 IS A CASCADE OF FAILURE FROM FC 810:11. FAILURE CODE 810:11 WAS DUE TO AN OUT OF CALIBRATION AIR-IN-LINE PRINTED CIRCUIT BOARD. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED AND VERIFIED TO CORRECT THE REPORTED CONDITION. (B)(4).

    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. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION "812.05". IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. THE CUSTOMER HAS DECLINED TO BE CONTACTED. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS UNREMEDIATED. DURING REVIEW OF THE EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT 812:05 IS A CASCADE FAILURE FROM FC 810:11 WHICH OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    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