BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2143439 · Received June 29, 2011

    Report

    Report Number
    6000001-2011-09172
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 9, 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). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A LOT NUMBER WAS NOT REPORTED, SO A BATCH REVIEW CANNOT BE CONDUCTED. 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 U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(6) RECEIVED A REPORT FOR ONE (1) INFUSOR DEVICE WHICH INTERRUPTED DELIVERY DURING PATIENT USE AT THE HOSPITAL. FLOW OF MEDICATION WAS OBSERVED AT THE BEGINNING THERAPY, BUT THE DELIVERY STOPPED PREMATURELY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION. THE DEVICE WAS FILLED WITH ROPIVACAINE HYDROCHLORIDE HYDRATE. NO ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ROPIVACAINE HYDROCHLORIDE HYDRATE