BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAHP-150 CELLULOSE DIACETATE DIALYZER

    MDR report key: 1891586 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05299
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 12, 2010
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    MSF
    PMA / PMN Number
    K970653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB. THE EVALUATION FOUND THAT THERE WAS LEAKAGE AT THE VENOUS HEADER AND BUBBLING OUT OF THE DIALYSATE PORT. NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE LOT. A REVIEW OF THE MANUFACTURING, PROCESS INSPECTION AND RELEASE INSPECTION RECORDS WAS PERFORMED AND NO DEFECTS WERE NOTED. IN ADDITION, TESTING OF THE RETAINED SAMPLES SHOWED NO ABNORMALITIES. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE/PRODUCT SAMPLE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER AN INCIDENT INVOLVING A DIALYZER. THE CUSTOMER STATED THAT THERE WAS A LEAK AT THE FIBER AT THE 4TH TIME OF REUSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAHP-150 CELLULOSE DIACETATE DIALYZER HEMODIALYZER, RE-USE, HIGH FLUX MSF NIPRO CORPORATION *USD* 09G02D

    Patients

    Seq Age Sex Outcome Treatment
    1