BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL K+4 CLEARFLEX 5L (CE MARK)

    MDR report key: 1880087 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04761
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO SAMPLES WERE RECEIVED AND EVALUATED ON AN UNKNOWN DATE. THIS REPORT OF A SPLIT ON THE LEFT SIDE OF THE UPPER SEAM WAS CONFIRMED. A REVIEW OF THE BATCH FILE WAS FOUND TO BE ACCEPTABLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS HANDLING RELATED. A THIRD FILLING MACHINE WITH AN UPGRADED SEALING PROCESS WAS VALIDATED FOR THIS PRODUCT AND INTRODUCED IN (B)(4) 2010. THE UPGRADED SEALING PROCESS WAS COMPLETED IN (B)(4) 2010. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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

    THE ACCUSOL BAG SPLIT ON THE LEFT SIDE OF THE UPPER SEAM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL K+4 CLEARFLEX 5L (CE MARK) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10B26G70

    Patients

    Seq Age Sex Outcome Treatment
    1