BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192465 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10303
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CAUSE OF THE EVENT WAS DETERMINED TO BE BURNED MATERIAL DUE TO PARAMETER VARIATION DURING TUBE MANUFACTURING. A BATCH REVIEW WAS PERFORMED AND FOUND NO ISSUES RELATED TO THE MANUFACTURING OF THE LOT NUMBER. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A 510K 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 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE WIFE OF A PATIENT CONTACTED BAXTER QUALITY ASSURANCE AND REPORTED PARTICULATE MATTER WITH 1 HOMECHOICE CASSETTE UNIT. IT WAS INFORMED THAT WHEN HE TRIED TO CONNECT THE SET, HE FOUND PARTICULATE MATTER INSIDE THE SET. THE SET WAS SEALED AND HE SAW IT BEFORE CONNECTING THE SET. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - CALI SE11CE3

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE