BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI REXEED SERIES DIALYZER

    MDR report key: 1567339 · Received December 30, 2009

    Report

    Report Number
    3007340888-2009-00004
    Event Type
    Other
    Date Received
    December 30, 2009
    Date of Event
    November 9, 2009
    Report Date
    November 23, 2009
    Manufacturer
    ASAHI KASEI KURARAY MEDICAL CO., LTD.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL USED DIALYZER WAS NOT RETURNED TO US FOR INVESTIGATION. HYPOTENSION, HEADACHE COULD OCCUR DURING DIALYSIS TREATMENT SUCH AS PT CONDITION (INCLUDING PRIMARY DISEASE AND TREATMENT CONDITION), DIALYZER (MEMBRANE MATERIAL AND COMPATIBILITY), BLOOD TUBING, OPERATING CONDITION, TREATMENT CONDITION, COMBINED MEDICINE INCLUDING ANTICOAGULANTS AND OTHERS. THE CAUTION FOR THESE EVENTS ARE DESCRIBED IN INSTRUCTION FOR USE. ADD'L INFO, LOT NUMBER OF THE DIALYZER USED FOR THIS PT IS UNK, BUT AFTER REVIEWING THE SHIPPING HISTORY TO THIS HOSP, IT IS LIKELY THAT EITHER #09ZJ18 OR #193M3T WAS USED. WE, THEREFORE, REVIEWED THE MFG AND QUALITY CONTROL RECORDS FOR THE DIALYZER OF LOT NO. #09ZJ18 AND #193M3T, AND NO ABNORMALITY WAS FOUND IN THE RECORDS.

    Description of Event or Problem · 1

    ON (B)(6) 2009 AT ONSET OF TREATMENT PT COMPLAINS OF HEADACHE, SWOLLEN TONGUE, HYPOTENSION TO 60 MMHG. DIALYSIS STOPPED, PT TREATED WITH I.V. BENADRYL AND PREDNISONE AND SENT TO EMERGENCY ROOM. AS ADD'L INFO, THIS WAS SECOND TREATMENT ON THIS DIALYZER (REXEED-21SX). THE NEXT TREATMENT WAS DONE IN A HOSP ON A DIALYZER OF A DIFFERENT MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI REXEED SERIES DIALYZER KDI ASAHI KASEI KURARAY MEDICAL CO., LTD. REXEED-21SX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization