BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI REXEED SERIES DIALYZER

    MDR report key: 1443190 · Received August 19, 2009

    Report

    Report Number
    3007340888-2009-00002
    Event Type
    Other
    Date Received
    August 19, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 14, 2009
    Manufacturer
    ASAHI KASEI KURARAY MEDICAL CO. LTD.
    Product Code
    KDI
    PMA / PMN Number
    K082515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER AND COULD NOT BE EVALUATED. WE THEREFORE, REVIEWED THE MANUFACTURING AND CONTROL RECORDS FOR THE DIALYZERS OF LOT NO. 193V47, AND NO ABNORMALITY WAS FOUND IN THE RECORDS.

    Description of Event or Problem · 1

    DURING DIALYSIS TREATMENT, THE PATIENT HAD CHILLS AND GRAND MAL SEIZURE, BUT BP STABLE, WAS EMERGENTLY TRANSPORTED TO HOSPITAL AND DIED. AS ADDITIONAL INFORMATION, PRELIMINARY DISEASE OF THE PATIENT WAS DIABETES AND THE PATIENT WAS INTRODUCED HEMODIALYSIS WITH REXEED-18SX DIALYZER ON (B)(6)2009. (B)(6)2009 (1ST TREATMENT): PATIENT HAD FIRST USE REACTION, CHILLS AND BP DROP DURING THE DIALYSIS TREATMENT. (B)(6)2009 (2ND TREATMENT): NO PROBLEM.

    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 193V47

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization