BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3874598 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19129
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 13N040 WAS MANUFACTURED BETWEEN DECEMBER 15, 2013 AND DECEMBER 16, 2013. THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON RECEIPT, VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE) NOTED FLUID AROUND THE AREA OF THE TURN DIAL LOCATED ON THE MULTIRATE CONTROL MODULE. A FUNCTIONAL LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE UNIT WITH GREEN COLORED WATER. AFTER FILL, GREEN WATER WAS VISUALLY OBSERVED AROUND THE AREA OF THE TURN DIAL LOCATED ON THE MULTIRATE CONTROL MODULE. CONSEQUENTLY, THE REPORTED LEAK WAS VERIFIED. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE CONTROL MODULE OF A MULTIRATE INFUSOR WAS LEAKING. THE REPORTER STATED THAT THIS PREVENTED THE DELIVERY OF THE MEDICATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352264 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N040

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR BUPIVACAINE 0.5%, 60ML| NORMAL SALINE, 240ML