BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3223761 · Received July 10, 2013

    Report

    Report Number
    1713747-2013-00259
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 11, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PT EXPERIENCED AN EVENT 5-10 MINUTES INTO TREATMENT THAT REQUIRED THE PT TO BE SENT TO THE EMERGENCY ROOM. THE PT'S RN REPORTED THAT THE EVENT WAS RELATED TO A DIALYZER REACTION. CURRENTLY, THE PT'S PRESCRIPTION WAS CHANGED TO A NON-FRESENIUS DIALYZER AND THE PT IS REPORTED TO BE DOING GREAT. BASED ON THE PRESCRIPTION CHANGE, A SERIOUS INJURY MDR IS BEING FILED. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, A MANUFACTURING REVIEW CANNOT BE PERFORMED. HOWEVER, RECORD REVIEW OF EACH LOT AND CATALOG NUMBER RECEIVED BY THE CUSTOMER FOR THE MOST RECENT 3 MONTHS HAVE BEEN SCREENED. THE SYMPTOM CODE HAS NOT EXCEEDED THE ALERT LIMIT. REF MDR'S: 1713747-2013-00258, 1713747-2013-00259, 1713747-2013-00260.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 5-10 MINUTES INTO TREATMENT, THE PT HAD A CARDIAC ARREST. THE EVENT EXPERIENCED OCCURRED ON THREE DIFFERENT DATES ((B)(6) 2013). THE REASON FOR THE PT REACTIONS IS UNK. THE PT WAS SWITCHED TO BAXTER EXCELTRA DIALYZER AND NO SYMPTOMS WERE EXPERIENCED. FOLLOW-UP WITH THE PT'S RN STATED THAT THE PT HAS BEEN DOING GREAT SINCE THE DIALYZER CHANGE. BASED ON TREATMENT SHEET FOR (B)(6) 2013: PRE WEIGHT: (B)(6), PRE TEMP: 98.3, POST TEMP: 97.3. AT 12:01PM, PT ALERT, RESTING COMFORTABLY. TREATMENT INITIATED WITHOUT PROBLEM. AT 12:03PM, PT ALERT, RESTING COMFORTABLY. AT 12:08PM, PT ALERT, COMPLAINTS OF CHEST DISCOMFORT, PT STATED SHE HAD SYMPTOM RELIEF, APPLIED O2 3 LITERS. AT 12:51PM, PT ALERT DENIES COMPLAINTS. AT 13:00PM, PT ALERT DENIES COMPLAINTS, 100CC NA FLUSH DUE TO PT CLOT. AT 12:33PM, PT ALERT DENIES COMPLAINTS, 100CC NA FLUSH. AT 14:04PM, PT ALERT DENIES COMPLAINTS, 100CC NA FLUSH. AT 14:38PM, PT ALERT DENIES COMPLAINTS, 100CC NA FLUSH. AT 15:10PM, PT ALERT DENIES COMPLAINTS, TREATMENT COMPLETED WITHOUT PROBLEM. POST-DIALYSIS NOTES: TOLERATED TREATMENT. SYSTEM CLOTTED BUT PT REFUSED TO HAVE ANOTHER SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316209 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R 2008 K MACHINE