BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0311 RE-MANUFACTURED IPUMP

    MDR report key: 2022835 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01964
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF AIR IN THE LINE AND THE PUMP DID NOT DETECT IT WAS CONFIRMED THROUGH EVALUATION. THE DEVICE FAILED THE AIR SENSOR TEST. THE AIR SENSOR WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING AN IPUMP WITH AIR IN THE LINE AND THE PUMP DID NOT DETECT IT. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0311 RE-MANUFACTURED IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1