BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 1051623 · Received May 22, 2008

    Report

    Report Number
    1713747-2008-00008
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 21, 2008
    Manufacturer
    OGDEN MFG
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING RN HAS STATED THAT ONE OF THE MD'S INVOLVED IN THE CARE OF THIS PT HAS QUESTIONED WHETHER THIS IS A DIALYZER REACTION. THE RN AND THE MEDICAL DIRECTOR OF THE UNIT HOWEVER, DO NOT. THE RN STATED THAT THIS PT APPEARS TO SHOW SIGNS OF ANXIETY. THE RN ALSO REPORTED THAT THIS PT IS ABLE TO TOLERATE THE TREATMENT WITH USE OF THIS DIALYZER. THE RN HAS ALSO QUESTIONED THE CATHETER AND THE HIGH BLOOD FLOW RATE AND FEELS THE EVENT COULD BE POSSIBLY RELATED TO THE CATHETER. SINCE SOME PRESCRIPTION CHANGES HAVE OCCURRED, THE RN ALSO STATED THAT THEY CANNOT DETERMINE THE CAUSE OF THE REACTION DUE TO THE ANTI-DEPRESSANT AND DIALYZER BEING CHANGED AT THE SAME TIME.

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT HAD BEEN RECEIVED FROM A HEMODIALYSIS USER FACILITY. IT HAS INITIALLY BEEN REPORTED THAT AT ONE HOUR INTO THE DIALYSIS TREATMENT, THIS PT WAS FOUND UNRESPONSIVE, BUT MAINTAINED A WEAK PULSE. THE FACILITY HAS BEEN CONTACTED FOR ADD'L DETAIL OF THE EVENT. IT HAS BEEN LEARNED THAT THE PT DOES HAVE A CATHETER FOR THE DIALYSIS ACCESS. THE PT WAS FOUND TO BE IN ATRIAL FIBRILLATION AT THE TIME OF THIS EVENT. THE PT HAD GAINED 3 KILOGRAMS OF FLUID AND WAS UNDERGOING DIALYSIS WITH STABLE BLOOD PRESSURES, WHEN AT 1 HOUR INTO THE TREATMENT, THE BLOOD PRESSURE WAS NOTED TO BE 117/87, AND THEN IT WAS REPORTED AS THE PT "PASSED OUT". THE HEALTH CARE TEAM CALLED 911, GAVE A NORMAL SALINE BOLUS, APPLIED THE AED, OXYGEN WAS GIVEN, AND IT WAS NOTED THAT THE PT WAS RECOVERING. THE BLOOD CONTAINED IN THE TREATMENT SET WAS ALSO RETURNED BACK TO THIS PT. AND NOW, REPORTEDLY, THE PT HAD A BLOOD PRESSURE OF 160/88 AND A PULSE OF 95 AND WAS ALERT AND RESPONSIVE. THE PT WAS TRANSPORTED BY THE PARAMEDICS TO THE HOSPITAL FOR FURTHER EVAL. THE PT WAS EVALUATED AT THE HOSPITAL AND WAS DISCHARGED TO HER HOME. TO DATE, THIS PT HAS BEEN PRESCRIBED AN ANTIDEPRESSANT, AND IS RECEIVING DIALYSIS WITH A DIFFERENT BRAND OF DIALYZER. IT IS REPORTED THE PT IS STABLE AT THIS TIME. THE STAFF IS CURRENTLY PERFORMING DIALYSIS WITH A LOWER BLOOD FLOW RATE AND IN 2007, THEY REPORTED THEY WERE ABLE TO INCREASE THE BLOOD FLOW RATE. THE RN ALSO REPORTED THIS PT IS HIGHLY ANXIOUS AND THAT SHE FREQUENTLY CUTS SHORT HER DIALYSIS TIME. THE SAMPLE IS AVAILABLE FOR AN EVAL. THE PT DOES HAVE A CATHETER FOR THE DIALYSIS ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER KDI OGDEN MFG NA 7SU115

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R