BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, ELASTOMERIC

    MDR report key: 1945136 · Received January 3, 2011

    Report

    Report Number
    6000001-2011-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED BY BAXTER. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION AND RETRIEVAL OF THE SAMPLE; THE CUSTOMER HAS NOT YET RETURNED ANY OF BAXTER'S COMMUNICATION ATTEMPTS. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION OF AN OVERINFUSION. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT ONE (1) DISPOSABLE INFUSION PUMP (UNKNOWN PRODUCT INFORMATION) "FINISHED EARLY" DURING PATIENT USE. THERE WAS NO ADDITIONAL INFORMATION EMAILED FROM THE CUSTOMER. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F069

    Patients

    Seq Age Sex Outcome Treatment
    1