BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2132959 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07980
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STATED REPORTED CONDITION IN THE INITIAL MEDWATCH REPORT WAS A DUPLICATE OF MEDWATCH REPORT, 6000001-2011-08524. THE ACCURATE REPORTED CONDITION FOR THIS COMPLAINT IS THAT THE CUSTOMER REPORTED THAT THE "SELECT" KEYPAD BUTTON WAS INOPERATIVE AT CHANNEL A.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS PHYSICAL DAMAGE TO THE PUMPHEAD MODULE KEYPAD. THE PUMPHEAD MODULE KEYPAD HAS BEEN REPLACED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT A COLLEAGUE INFUSION PUMP IN WHICH FAILURE CODE 500:320:658:0000 OCCURRED ON CHANNEL A. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.48.92, CATEGORIZED AS REMEDIATED.

    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