BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT

    MDR report key: 1883547 · Received October 26, 2010

    Report

    Report Number
    6000001-2010-04534
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    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 A LEAK. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT A BASAL/BOLUS INFUSOR DEVICE WAS LEAKING FROM THE CONNECTION BETWEEN THE DEVICE TUBING AND THE FILTER OF CATHETER (B.BRAUN AESCULAP) DURING PATIENT USE. THE DEVICE WAS INFUSING THE PATIENT WITH 0.55 MILLILITERS MORPHINE HYDROCHLORIDE, 2 MILLILITERS DROPERIDOL, AND 200 MILLILITERS 0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE WHEN LEAKAGE WAS OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F029

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) AESCULAP CATHETER