BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 2243436 · Received September 12, 2011

    Report

    Report Number
    6000001-2011-23899
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF AN IPUMP THAT DRAINS THE THREE 9 VOLT BATTERIES IN ONE USE WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED. DUE TO ESTIMATE REFUSAL BY THE CUSTOMER, NO REPAIRS WERE MADE TO FIX THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN IPUMP WITH A CONDITION OF DRAINS THREE 9 VOLT BATTERIES IN ONE USE. THIS CONDITION OCCURRED DURING DELIVERY IN THE LABOR AND DELIVERY UNIT DEPARTMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY 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