BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NR DIALYZER FINISHED ASSEMBLY

    MDR report key: 3935822 · Received June 23, 2014

    Report

    Report Number
    1713747-2014-00316
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INCIDENT OF ANXIETY, BURNING AND ITCHING DURING HEMODIALYSIS TREATMENT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINICAL MGR REPORTED THE PT DEVELOPED ITCHING, BURNING, AND ANXIETY APPROXIMATELY 1.5 HRS INTO THE HEMODIALYSIS TREATMENT. SHE FURTHER REPORTS THE PT WAS GIVEN "BENADRYL" WITH GOOD EFFECT. TREATMENT WAS DISCONTINUED. THE BLOOD WAS NOT RETURNED (EBL=300 ML) PER PHYSICIAN ORDER AND THE TREATMENT WAS CANCELLED FOR THE DAY. NO ADD'L MEDICAL INTERVENTION WAS REQUIRED. SHE WAS CHANGED TO ANOTHER DIALYZER FOR SUBSEQUENT TREATMENTS WITHOUT FURTHER RECURRENCE OF SYMPTOMS AND IS CONTINUING ON HEMODIALYSIS. ACCORDING TO MEDICAL RECORDS RECEIVED, THE TREATMENT WAS INITIATED AT 11:59 AM. THE PT REPORTED "ITCHING" AT 13:07 PM AND WAS GIVEN 12.5MG BENADRYL INTRAVENOUS PUSH WITH GOOD EFFECT. THE SYMPTOMS OF "SEVERE ITCHING AND BURNING OCCURRED AT 14:30 PM AND THERE WAS NO DOCUMENTATION OF MEDICATION GIVEN. TREATMENT WAS ENDED AT 14:42 PM WITH PT STATING "BURNING/ITCHING SUBSIDED" AND "ORDER RECEIVED TO DISCONTINUE TREATMENT FOR TODAY AND DO NOT REINFUSE BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367027 OPTIFLUX 180NR DIALYZER FINISHED ASSEMBLY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14AU03009

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 2008K HEMO MACHINE| 2K 2.5 CA+1MG 100 DEXTROSE ACID CONCENTRATE| FRESENIUS BICARB| FRESENIUS COMBISET| FRESENIUIS SALINE