BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3891405 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20064
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM FEBRUARY 14, 2014 TO FEBRUARY 15, 2014. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED. INSPECTION OF THE PHOTOGRAPH WAS UNABLE TO VERIFY THE REPORTED CONDITION AS THERE WAS NO CLEAR EVIDENCE OF A LEAK. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAKING INFUSOR ELASTOMERIC DEVICE. THE DEVICE WAS FILLED WITH FLUCLOXACILLIN. IT IS UNKNOWN WHETHER OR NOT THIS EVENT OCCURRED DURING PATIENT USE. HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED TO BE IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367746 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B028

    Patients

    Seq Age Sex Outcome Treatment
    1