BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3223738 · Received July 10, 2013

    Report

    Report Number
    1713747-2013-00258
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 4, 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. REFERENCE 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 A 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 FROM (B)(6) 2013: PRE WEIGHT: (B)(6), PRE TEMP: 99.5, POST TEMP: 98.6, PRE PULSE: 84R, POST PULSE: 80R. AT 11:53, PT BEGAN TREATMENT. AT 11:54, PT ALERT, TREATMENT INITIATED WITHOUT PROBLEM. AT 11:59AM, PT ALERT. PT COMPLAINTS OF NOT FEELING RIGHT, NURSE CALLED AND O2 2 LITERS APPLIED. AT 12:13PM, TREATMENT COMPLETED. POST-DIALYSIS NOTES: AMBULATORY-VSS. CONTINUES TO COMPLAIN OF COUGHING. LUNGS SOUND COURSE WITH RUBS AND WHEEZING, MILD PEDAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315043 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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