BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3211656 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17736
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED, BUT A PHOTOGRAPHIC IMAGE WAS PROVIDED FOR EVALUATION. THE EVALUATION IS ANTICIPATED AND UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INSPECTION OF THE PHOTOGRAPH DID NOT IDENTIFY EVIDENCE OF THE REPORTED LEAK. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR CONTAINING 6000 MG OF FLUCLOXACILLIN WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311566 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12K039

    Patients

    Seq Age Sex Outcome Treatment
    1