BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1982999 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00809
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: THE FACILITY REPORTED AN INFUSO.R THAT ALARMS WHEN INFUSION IS STARTED. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. THE CONDITION OCCURRED IN THE BIOMED SERVICE DEPARTMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION:THE CONDITION OF A INFUSO.R. WITH AN ALARM CONDITION WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS NOT DETERMINED AND NO REPAIRS WERE MADE IN ORDER TO FIX THE REPORTED CONDITION. A FOLLOW-UP MDR WILL BE SENT WHEN ADDITIONAL INFORMATION IS AVAILABLE.A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP THAT ALARMS WHEN INFUSION IS STARTED. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. THE CONDITION OCCURRED IN THE BIOMED SERVICE DEPARTMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1