BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI REXEED SERIES DIALYZER

    MDR report key: 1439437 · Received August 14, 2009

    Report

    Report Number
    3007340888-2009-00001
    Event Type
    Other
    Date Received
    August 14, 2009
    Date of Event
    June 29, 2009
    Report Date
    July 6, 2009
    Manufacturer
    ASAHI KASEI KURARAY MEDICAL CO. LTD.
    Product Code
    KDI
    PMA / PMN Number
    K082515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WAS NOT RETURNED TO THE MFR AND COULD NOT BE EVALUATED. WE THEREFORE, REVIEWED THE MFG AND QUALITY CONTROL RECORDS FOR THE DIALYZERS OF LOT # 193S43, AND NO ABNORMALITY WAS FOUND IN THE RECORDS. IT WAS REPORTED THAT THE PT WAS ELDERLY AND SOMEWHAT FRAGILE, AND THE NURSE WAS CONCERNED WITH THE PT'S CANNULATION. FROM THE ABOVE FACTS AND INFO, WE SUPPOSE THAT THE REPORTED EVENT MIGHT NOT BE CAUSED BY THE DIALYZER USED FOR THE PT.

    Description of Event or Problem · 1

    THE PT IS APPARENTLY AN ELDERLY AND SOMEWHAT FRAGILE. STARTED DIALYSIS (B)(6) 2009. NURSE REPORTED ANXIETY ESP. WITH CANNULATION PROBLEM. ON (B)(6) 2009, BLOOD PRESSURE FELL FROM 116/54 TO 71/55 AT THE ONSET OF THE TREATMENT, AND THE PT COMPLAINED OF BILATERAL BACK PAIN. AN ADDITIONAL INFO, THE NEXT TREATMENT WAS DONE IN A HOSP ON A DIALYZER OF A DIFFERENT MFR. THE PT INFORMED STAFF THAT HE HAD 1ST USE SYNDROME SO NEEDS SLOWER QB. TREATMENT WAS BEGUN @200ML/MIN AND WHEN THE PT FELL ASLEEP, QB WAS INCREASED TO 300ML/MIN WITHOUT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI REXEED SERIES DIALYZER KDI ASAHI KASEI KURARAY MEDICAL CO. LTD. REXEED-18SX 193S43

    Patients

    Seq Age Sex Outcome Treatment
    1 Other