BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICE CASSETTE C/LINEASPIGM.

    MDR report key: 1903759 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06046
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 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). THIS COMPLAINT FOR A LEAK IN A CASSETTE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED.

    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. A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE SAMPLE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK IN A CASSETTE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO BAXTER (B)(4) A LEAK IN A CASSETTE. THE LEAK WAS NOTED IN A SECTION OF THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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. 20RHHC

    Patients

    Seq Age Sex Outcome Treatment
    1