BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF 1200 RENAFLO II HEMOFILTER

    MDR report key: 1964296 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00782
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Manufacturer
    MINTECH
    Product Code
    KDI
    PMA / PMN Number
    K923312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. THIS COMPLAINT COULD NOT BE CONFIRMED FOR A LEAK. THE SAMPLE WAS SENT TO THE MANUFACTURER FOR EVALUATION AND COULD NOT BE CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4), THAT DURING PREFILLING, A LEAK WAS OBSERVED AT THE ARTERIAL PORT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HF 1200 RENAFLO II HEMOFILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MINTECH 649847A

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE