BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIRATE INFUSOR LV 2,3,5,12PACK FOR JAPAN ONLY

    MDR report key: 2032144 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02278
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MISASSEMBLED CONDITION CONFIRMED. VISUAL EXAMINATION OF THE UNIT FOUND THE ROOT CAUSE OF FLUID IN THE HOUSING TO BE A MISSING FILM-WRAP. THE ROOT CAUSE OF THE MISASSEMBLED CONDITION WAS DUE TO OPERATOR ERROR DURING THE FILM WRAP ASSEMBLY PROCESS. AS A RESULT OF THIS INCIDENT, THE COMPLAINT SAMPLE WAS USED TO BRING AWARENESS TO ALL APPLICABLE MANUFACTURING OPERATORS. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) MULTIRATE INFUSOR LV DEVICE WAS OBSERVED LEAKING WITHIN THE HOUSING DURING FILLING. THE DEVICE WAS BEING FILLED WITH ROPIVACAINE HYDROCHLORIDE HYDRATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIRATE INFUSOR LV 2,3,5,12PACK FOR JAPAN ONLY PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M047

    Patients

    Seq Age Sex Outcome Treatment
    1 ROPIVACAINE HYDROCHLORIDE HYDRATE