BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 1870945 · Received October 7, 2010

    Report

    Report Number
    1713747-2010-00039
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 8, 2010
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A HEMODIALYSIS USER FACILITY OF A POSSIBLE DIALYZER REACTION. THE FOLLOWING INFO WAS RECEIVED: THAT THE PT HAS A NEW ONSET OF COUGHING. THE FACILITY WAS CONTACTED WHERE IT WAS LEARNED THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2010 FOR FURTHER EVALUATION OF THE COUGH. HE WAS FAIRLY NEW TO THIS CLINIC HAVING STARTED DIALYSIS IN (B)(6) OF 2010. HE HAS A CATHETER THAT IS USED FOR HEMODIALYSIS. THE RPTR OF THIS EVENT REPORTED THAT HE WOULD RECEIVE DIALYSIS AND COUGH AND THE COUGHING WOULD GET WORSE EVEN WHEN HE WENT HOME AND HIS CONDITION WOULD SLOWLY IMPROVE. FOR THIS EVENT, THE PT WAS FURTHER EVALUATED. THE PT WAS PLACED ON A DIFFERENT BRAND OF DIALYZER FOR DIALYSIS. IT WAS REPORTED BY THE NURSE THAT AT THIS TIME, THE PT HAS NO FURTHER SYMPTOMS. THERE IS NO SAMPLE AND THE LOT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER KDI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R CATHETER: MAKE AND MODEL IS UNK