BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM 190G SYNTH HF DIALYZER

    MDR report key: 1850584 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-04001
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS OBTAINED ON 10/06/2010 BY BAXTER (B)(4): THE CUSTOMER INDICATED THAT THE DIALYZERS WERE REPORTED TO HAVE LEAKS BECAUSE WHEN THE CIRCUIT WAS PRIMED WITH SALINE SOLUTION, A 'STRING' OF THE SOLUTION WAS OBSERVED INSIDE THE DIALYZER BUT OUTSIDE OF THE CAPILLARIES, AND THE BLUE AND RED COUPLES OF THE MACHINE (THE CONNECTORS OF THE LINES THAT CARRY THE DIALYZING FLUID FROM THE MACHINE TO THE DIALYZER) HAD NOT BEEN CONNECTED TO THE DIALYZER YET. IT WAS ASSUMED THAT THE FLUID WAS CAUSED BY THE RUPTURE OF THE MEMBRANE, AND THE DIALYZER WAS IMMEDIATELY REPLACED FOR A NEW ONE FOLLOWING THEIR ROUTINE PROCEDURE. THE CUSTOMER ALSO INDICATED THAT NO TESTS HAD BEEN PERFORMED ON THE DIALYZERS AND CONCLUSIONS WERE BASED ONLY ON OBSERVATIONS MADE BY PERSONNEL WHO HANDLED THE DIALYZER; HE WAS NOT PRESENT AT THE TIME OF THE EVENTS, SO HE WAS UNABLE TO PROVIDE FURTHER DETAILS. INFORMATION REGARDING MEMBRANE PERMEABILITY WAS REINFORCED WITH THE CUSTOMER. THIS MEMBRANE IS PRONE TO BE PERMEABLE WHEN IT COMES INTO CONTACT WITH THE SALINE SOLUTION AND IT IS NORMAL TO OBSERVE FLUID WITHIN THE DIALYZER'S BODY BEFORE CONNECTING THE COUPLERS. BAXTER OFFERED TO PROVIDE RETRAINING TO THE CUSTOMER'S FACILITY. HOWEVER, THE CUSTOMER INDICATED THAT IN THE EVENT THAT IT IS CONSIDERED APPLICABLE, TRAINING WILL BE PROVIDED BASED ON THEIR INTERNAL TRAINING PROCESSES. BASED ON THE ABOVE, THE PROBLEM IDENTIFIED WITH THE CUSTOMER IS THE RESULT OF INAPPROPRIATE HANDLING OF DIALYZERS OR LACK OF KNOWLEDGE REGARDING THE MEMBRANES' NORMAL PERMEABILITY WHEN IT CONTACTS THE SALINE SOLUTION. THE DIALYZERS WERE NEVER IN CONTACT WITH ANY PATIENT BLOOD THUS, IT IS NOT POSSIBLE TO IDENTIFY MEMBRANE RUPTURE DUE TO THE PRESENCE OF DIALYZING SOLUTION INSIDE AND OUTSIDE THE CAPILLARIES. NO FURTHER INFORMATION IS AVAILABLE. A MANUFACTURING BATCH RECORD REVIEW AND RETENTION SAMPLE REVIEW WAS PERFORMED. IT WAS INDICATED THAT THE MANUFACTURING RECORDS, PROCESS INSPECTION RECORDS AND RELEASE INSPECTION RECORDS OF THE CONCERNED LOT WERE REVIEWED AND NO ABNORMALITY WAS FOUND. THE LOT WAS CONFIRMED TO HAVE BEEN MANUFACTURED UNDER NORMAL CONDITION. IT WAS INDICATED THAT RETAINED SAMPLES OF THE CONCERNED LOT WERE CHECKED VISUALLY AND NO DAMAGE WAS FOUND ON THE HOLLOW FIBERS. ALSO, A LEAK TEST WAS PERFORMED ON RETAINED SAMPLES UNDER FLOODED CONDITIONS AFTER PRIMING AND NO LEAK FROM FIBERS OR OTHER PLACES WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 FOR THE QUANTITY OF 2 REPORTED BY THE CUSTOMER FOR THIS LOT NUMBER. ADDITIONAL INFORMATION OBTAINED ON (B)(6) 2010: THE LOT NUMBER WAS PROVIDED AND THE QUANTITY WAS PROVIDED (2). A BAXTER (B)(4) HAS BEEN IN CONTACT (I.E TELEPHONE CALLS AND VISIT) WITH THE CUSTOMER, WHO IS IN CHARGE OF THE INFIRMARY UNIT; HOWEVER SHE HAS NOT PROVIDED DETAILS OF THE EVENT AS OF YET. THE BAXTER (B)(4) CONTINUES TO REQUEST THE EVENT DETAILS. 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

    THE CUSTOMER (B)(6) ((B)(6)) REPORTED TO THE EXECUTIVE ACCOUNT THAT IT WAS IDENTIFIED THAT THERE WERE SEVERAL DIALYZERS WITH LEAKS. NO INJURY TO A PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM 190G SYNTH HF DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION USD 09G30S

    Patients

    Seq Age Sex Outcome Treatment
    1