BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3213989 · Received July 3, 2013

    Report

    Report Number
    1713747-2013-00250
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    March 29, 2013
    Report Date
    June 5, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TREATMENT SHEETS AND PT DEMOGRAPHICS HAVE BEEN REQUESTED. THIS MDR INCLUDES ALL INFORMATION RECEIVED TO DATE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE'S DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. IN ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MDR #S: 1713747-2013-00249, 1713747-2013-00251.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DIALYZER WAS SUSPECTED TO CAUSE SYNCOPE, RESPIRATORY FAILURE ON THE PT DURING DIALYSIS. THE SYMPTOMS OCCURRED DURING THE FIRST 15 MINUTES OF DIALYSIS. EVENTS OCCURRED ON (B)(6) 2013. THE PT WAS HOSPITALIZED FOR 60 DAYS AT WHICH TIME THE DIALYZER REACTIONS WERE EXPERIENCED. THE HOSPITAL PERFORMED A CATHETER CHANGE TO RULE OUT AS A SOURCE OF THE REACTION. THE PT'S PRESCRIPTION WAS CHANGED TO A NON-E-BEAM DIALYZER AND THE PT IS ADMINISTERED PREDNISONE AND BENADRYL PRIOR TO TREATMENT. THE REACTIONS HAVE BEEN ELIMINATED SINCE THE CHANGE. THE HOSPITAL CONCLUDED THE DIALYZER TO BE THE SOURCE OF THE REACTION. TREATMENT SHEETS AND PT DEMOGRAPHICS HAVE BEEN REQUESTED. NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304001 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13DU02011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention