BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4181834 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36285
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED ON JUNE 4, 2014 TO JUNE 5, 2014. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. THE DEVICE WAS RECEIVED WITH FLUID IN THE OVERPOUCH. VISUAL INSPECTION OF THE UNIT REVEALED AN UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH GREEN COLOR WATER AND TIGHTENING THE BLUE WINGED LUER CAP. THE TEST REVEALED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE CONDITION COULD NOT BE VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS NOTED AFTER FILLING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662265 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F009

    Patients

    Seq Age Sex Outcome Treatment
    1