BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICE CASSETTE C/LINEASPIGM.

    MDR report key: 1961373 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00611
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 23, 2010
    Manufacturer
    PLASTI ESTERIL, S.A. DE C.V.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CARE GIVER REPORTED TO BAXTER THAT AT THE MOMENT OF THE INFUSION A LEAK SEEN IN THE PATIENT LINE. NOT INJURY TO PATIENT WAS REPORTED; THE CASSETTE WAS REPLACED IMMEDIATLY AND THE PATIENT CONTINUED WITH THE THERAPY AS NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME CHOICE CASSETTE C/LINEASPIGM. SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX PLASTI ESTERIL, S.A. DE C.V. 49RJHC

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE CYCLER