BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOPTIFLUX 1809NRE DIALYZER FINISHED ASSY

    MDR report key: 3935821 · Received June 23, 2014

    Report

    Report Number
    1713747-2014-00317
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPT IS IN THE PROCESS OF REQUESTING PT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED ANXIETY, DYSPNEA AND HYPOTENSION WITH LOSS OF CONSCIOUSNESS AND HOSPITALIZATION. ACCORDING TO MEDICAL RECORDS, THE HOSP DISCHARGE SUMMARY LISTED FINAL DIAGNOSIS: "SYNCOPE, LIKELY SECONDARY TO HYPOTENSION IN SETTING OF HEMODIALYSIS." METABOLIC ACIDOSIS DUE TO ESRD ON HEMODIALYSIS. "LEUKOCYTOSIS, LIKELY STRESS RELATED, RESOLVED. HYPONATREMIA, MACROCYTIC ANEMIA, CHRONIC. ESSENTIAL HYPERTENSION. TYPE II DIABETES MELLITUS. HYPERLIPIDEMIA. ENTEROCOCCUS URINARY TRACT INFECTION, PRESENT ON ADMISSION AND CATHETER RELATED. OBESITY." A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINICAL MGR REPORTED, THE PT WHO HAD RECENTLY BEGUN HEMODIALYSIS PRESENTED TO TREATMENT IN HER USUAL STATE OF HEALTH. APPROXIMATELY 5 MIN INTO HEMODIALYSIS TREATMENT, SHE BEGAN TO EXPERIENCE SEVERE ANXIETY, DIFFICULTY BREATHING, AND HYPOTENSION. THE BLOOD WAS RETURNED AND SHE BECAME UNCONSCIOUS. AED WAS APPLIED AND IT SHOW SHE HAD A HEART RHYTHM. SHE WAS GIVEN A BOLUS OF NORMAL SALINE SOLUTION AND BECAME RESPONSIVE. EMS WAS CALLED AND SHE WAS TRANSPORTED TO THE HOSP WHERE SHE WAS ADMITTED. THE PT WAS DISCHARGED TO HOME ON AN UNK DATE AND CONTINUES ON HEMODIALYSIS USING A DIFFERENT DIALYZER. THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367137 FOPTIFLUX 1809NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13PU02015

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 2008T HEMODIALYSIS MACHINE| FRESENIUS BICARD| FRESENIUS COMBISET| FRESENIUS 3K 2.5 CA+ ACID BATH| FRESENIUS SALINE