BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACID CONC.7149 CF 3500ML CAPTI/F/D/NL CE

    MDR report key: 1862253 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04207
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BIEFFE MEDITAL S.P.A. - GROSOTTO ITALY
    Product Code
    FKQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT THE PRODUCT LEAKED IN THE OVERPOUCH BEFORE USE. THERE WAS NO PATIENT INJURY OR REACTION REPORTED. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACID CONC.7149 CF 3500ML CAPTI/F/D/NL CE SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT FKQ BIEFFE MEDITAL S.P.A. - GROSOTTO ITALY 09C2327

    Patients

    Seq Age Sex Outcome Treatment
    1