BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REXEED-S DIALYZERS

    MDR report key: 2992215 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00040
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    September 13, 2010
    Report Date
    March 1, 2013
    Manufacturer
    ASAHI KASEI MEDICAL CO., LTD.
    Product Code
    KDI
    PMA / PMN Number
    K051187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE COULD NOT BE ANALYZED BECAUSE IT WAS DISCARDED BY THE USER FACILITY. SO WE REVIEWED MANUFACTURING RECORDS, QUALITY RECORDS OF LOT# Q03J3P. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. THIRTEEN THOUSAND TWO HUNDRED AND THIRTY SIX UNITS OF THIS LOT# Q03J3P WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR SAE USING THIS LOT# Q03J3P WAS REPORTED GLOBALLY. THE SYMPTOMS OBSERVED IN THE EVENTS ARE CONSIDERED TO BE A DIALYZER REACTION. NOTE: THE DIALYZER REACTION IS A BROAD GROUP OF EVENTS THAT INCLUDE BOTH ANAPHYLACTIC AND LESS WELL-DEFINED ADVERSE REACTIONS OF UNKNOWN CAUSE. "HANDBOOK OF DIALYSIS 4TH ED." JOHN T DAUGIRDAS ET. AL., LIPPINCOTT, WILLIAMS & WILKINS, 2006.

    Description of Event or Problem · 1

    AN ELDERLY FEMALE PATIENT (PT) HAS BEEN DIALYZED USING REXEED R (RE-USE TYPE). ON (B)(6) /2010, THE DIALYZER (REXEED-15S; SINGLE USE TYPE) WAS USED FOR HEMODIALYSIS (HD). THREE MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 130 APPROXIMATELY 140 = 94MMHG). ADDITIONALLY SHORTNESS OF BREATH, FLUSHING OF FACE AND EXTREMITIES, ITCHY SENSATION HAPPENED. ON (B)(6) 2010, WITHIN 3 MINUTE START OF TREATMENT, PATIENT STATUS CHANGED FROM TALKING AND JOKING TO HEART RATE OF 140, RESPIRATIONS 40, "BEET RED" FACE, ITCHING TO RESPIRATORY FAILURE. PATIENT WAS INTUBATED AND SENT TO INTENSIVE CADRE UNIT ON VENTILATOR. HER STATUS BECAME STABLE AND RETURNED TO THE NURSING HOME ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88778 ASAHI REXEED-S DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. REXEED-15S Q03J3P

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening