BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS

    MDR report key: 5826244 · Received July 27, 2016

    Report

    Report Number
    2937457-2016-00786
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    June 11, 2016
    Report Date
    September 23, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THE BIOMEDICAL ENGINEER INDICATED THAT NO DEFICIENCIES WERE FOUND DURING HIS EVALUATION OF THIS MACHINE. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE

    Description of Event or Problem · 1

    A SPONTANEOUS SERIOUS UNEXPECTED REPORT OF HEART ATTACK WAS REPORTED TO FMCNA, LLC BY A BIOMEDICAL TECHNICIAN (BMT) ON (B)(6) 2016. THE REPORT CONCERNS A (B)(6) MALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CHRONIC IN-CENTER HEMODIALYSIS (HD). THE ORIGINAL DATE IN WHICH THIS PATIENT BEGAN RECEIVING THESE TREATMENTS IS UNKNOWN. A FOLLOW UP WAS COMPLETED WITH THE CLINIC MANAGER (CM) FOR EVENT DETAILS. ACCORDING TO THE CM, THE PATIENT WAS FOUND UNRESPONSIVE WITH 45 MINUTES REMAINING IN HIS SCHEDULED HD TREATMENT. THE PATIENT'S NURSE WAS UNABLE TO DETECT A PULSE. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED VIA 9-1-1, AND CPR WAS INITIATED. AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS PLACED ON THE PATIENT AND A SHOCK WAS GIVEN. A PULSE WAS REGAINED, HOWEVER, THE PATIENT WAS STILL NOT BREATHING. UPON ARRIVAL, THE EMS TOOK OVER EMERGENCY MEDICAL CARE. THE PATIENT WAS TRANSFERRED TO (B)(6). REPORTEDLY, PRIOR TO THE PATIENT'S ADMISSION TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT REGAINED CONSCIOUSNESS. HOWEVER, AS A RESULT OF BEING CONFUSED AS TO THE SERIES OF EVENTS LEADING TO THE HOSPITALIZATION, THE PATIENT WAS COMBATIVE, AND THEREFORE, WAS SEDATED. THE CM NOTED THE PATIENT'S ELEVATED TROPONIN LEVELS. THE HOSPITAL CONFIRMED THAT THE PATIENT HAD SUFFERED A HEART ATTACK WHILE ON THE HD TREATMENT. THE PATIENT WAS TREATED AND DISCHARGED ON (B)(6) 2016. THE PATIENT CONTINUES TO UNDERGO ROUTINELY SCHEDULED HD TREATMENTS AND THE PATIENT'S CURRENT CONDITION WAS NOTED AS BEING WELL. THE MACHINE WAS SEQUESTERED AND EVALUATED. THE MANAGER ADVISED THERE WERE NO ALARMS OR ABNORMALITIES WITH THE SYSTEM. THE PATIENT'S TREATMENT WAS RUNNING AS INTENDED PRIOR TO THE INCIDENT. THE MACHINE'S BLOOD LINES, DIALYZER, AND CONCENTRATE WERE NOT PRODUCTS MANUFACTURED BY FMCNA, LLC. A FOLLOW UP WITH THE FACILITY'S BMT WAS CONDUCTED. THE BMT CONFIRMED THE MACHINE WAS EVALUATED AND NO ALARMS, DEFICIENCIES, OR OTHERWISE ABNORMALITIES WERE IDENTIFIED. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479467 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R