BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K2 HEMODIALYSIS MACHINE

    MDR report key: 3936038 · Received June 23, 2014

    Report

    Report Number
    2937457-2014-01202
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE ALLEGED DEVICE MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED ALLEGATION OF DEVICE MALFUNCTION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMED TECHNICIAN CALLED TECHNICAL SUPPORT REPORTING THAT A NURSE HAD COMPLAINED THE UF PROFILE FEATURE OF THE MACHINE WAS NOT WORKING CORRECTLY. INSTEAD OF THE UF RATE DECREASING AS THE TREATMENT PROGRESSED IT INCREASED. SHE ALLEGES THIS CAUSED THE PATIENT TO CRAMP WHICH REQUIRED THE UF RATE TO BE LOWERED. TREATMENT OUTCOME AND ADDITIONAL PATIENT INFORMATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367060 2008K2 HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FRESENIUS DIALYZER| FRESENIUS COMBISET| FRESENIUS SALINE| FRESENIUS ACID AND BICARB