BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS HEMODIALYSIS DIALYZER

    MDR report key: 3192720 · Received June 21, 2013

    Report

    Report Number
    1713747-2013-00234
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K002277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMODIALYSIS MACHINE (PLANT INVESTIGATION) IS CURRENTLY UNDERGOING EVAL. BASED ON THE INFORMATION PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING MEDICAL RECORDS AND ADDITIONAL CLARIFICATION REGARDING THE REPORTED PT CODE DURING TREATMENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE PLANT INVESTIGATION AND CLINICAL INVESTIGATIONS ARE COMPLETED. THIS IS ONE OF 6 MDR'S SUBMITTED TO DOCUMENT THIS REPORTED EVENT. PLEASE REF THE FOLLOWING MDR NUMBERS: 8030665-2013-00391, 1713747-2013-99913, 1225714-2013-01159, 1225714-2013-01160, 1713747-2013-00085.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL TECH CONTACTED TECH SUPPORT ON (B)(6) 2013, REQUESTING A HEMODIALYSIS MACHINE FUNCTIONAL CHECK. THE FACILITY REQUESTED THIS CHECK FOLLOWING A REPORTED PT CODE DURING TREATMENT. CLINICAL DETAILS OF THE REPORTED PT CODE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283108 FRESENIUS HEMODIALYSIS DIALYZER KDI FRESENIUS MEDICAL CARE NORTH AMERICA 13DU06003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R SALINE| NATURALYTE| GRANUFLO| 2008T HEMODIALYSIS MACHINE| BLOODLINES