BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI REXEED SERIES DIALYZER

    MDR report key: 1554083 · Received November 25, 2009

    Report

    Report Number
    3007340888-2009-00003
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 23, 2009
    Manufacturer
    ASAHI KASEI KURARAY MEDICAL CO. LTD.
    Product Code
    KDI
    PMA / PMN Number
    K082515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL USED DIALYZER WAS NOT RETURNED TO US FOR INVESTIGATION. THROMBOCYTOPENIA COULD OCCUR DURING DIALYSIS TREATMENT AND/OR EXTRACORPOREAL TREATMENT FROM MULTIPLE FACTORS 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 THIS EVENT IS DESCRIBED IN INSTRUCTIONS FOR USE. THIS PT FREQUENTLY CLOTTED DIALYZER AND SYSTEM. THE SYSTEM CLOTTING MIGHT BE ATTRIBUTED TO THE REDUCTION OF THE BLOOD PLATELET.

    Description of Event or Problem · 1

    THE PT'S BLOOD WAS RETURNED BECAUSE HE WENT TO THE RESTROOM DURING DIALYSIS TREATMENT. THE SYSTEM WAS RECIRCULATED WHILE HE WAS OFF. THE PT HAD SEIZURE ACTIVITY WHEN THE DIALYSIS RESTARTED. BLOOD PRESSURE WAS HIGH INSTEAD OF LOW (NOT VASO-VAGAL RESPONSE). THE SYSTEM IMMEDIATELY CLOTTED EVEN THOUGH IT HAD LOOKED GOOD DURING RECIRCULATION. PRIMARY CONCERN IS THAT THE BLOOD PLATELET COUNT DROPPED FROM 90 PRE-DIALYSIS TO 10-12 POST DIALYSIS. (UNIT OF THE BLOOD PLATELET COUNT IS UNK). THE PT'S SKIN HAD PURPURA (PURPLE BLOTCHES). TTP AND HIT WAS RULED OUT. THE DIALYZER AND THE SYSTEM FREQUENTLY CLOT WITH CONCERNED PT. THIS PT DOES NOT RECEIVE HEPARIN. THE PT'S BLOOD PLATELET COUNT RETURNED TO NORMAL LEVEL ON THE OTHER DIALYZER. THE PT STARTED DIALYSIS ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI REXEED SERIES DIALYZER KDI ASAHI KASEI KURARAY MEDICAL CO. LTD. REXEED-25SX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization