BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 2170470 · Received July 21, 2011

    Report

    Report Number
    6000001-2011-13255
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. WHEN THE EVALUATION IS COMPLETE OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED 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. DEVICE EVALUATION: THE REPORTED CONDITION OF AN ON OFF BUTTON NOT WORKING INVOLVING AN IPUMP WAS NOT CONFIRMED NOR REPRODUCED DURING DEVICE EVALUATION. HOWEVER, DURING THE SAMPLE EVALUATION, THE KEYPAD WAS FOUND TO BE DELAMINATED. THE FRONT CASE WAS REPLACED TO FIX THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN IPUMP WITH A CONDITION OF THE ON OFF BUTTON NOT RESPONDING. THE PROCESS STEP IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, PATIENT INJURY, OR MEDICAL INTERVENTION ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1