BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992216 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00070
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    March 13, 2006
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. APS-15UA IS IDENTICAL MODEL TO REXEED-15U MARKETED IN US. THE USED DEVICE COULD NOT BE ANALYZED BECAUSE IT WAS DISCARDED BY THE USER FACILITY. SO WE REVIEWED MANUFACTURING RECORDS, QUALITY RECORDS OF LOT# P61L1S. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. FIVE THOUSAND EIGHT HUNDRED AND EIGHTY UNITS OF THIS LOT# P61L1S WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT# P61L1S 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

    ON (B)(6) 2006, THE DIALYZER (APS-15UA) WAS USED FOR HEMODIALYSIS (HD). TEN MINUTE AFTER START OF TREATMENT, BLOOD PRESSURE (BP) DECREASED (SYSTOLIC BLOOD PRESSURE: = 50 MMHG), LOSS OF CONSCIOUSNESS AND SHOCK WERE OCCURRED. AFTER THE ONSET OF THESE ADVERSE EVENTS (AES), OXYGEN 3L AND PHYSIOLOGICAL SALINE 500ML WERE ADMINISTERED. AFTER BLOOD PRESSURE RECOVERED PATIENT (PT) WENT BACK TO HOME. ON (B)(6) 2006, THE DIALYZER (APS-15UA) WAS USED FOR HEMODIALYSIS. FIFTEEN MINUTES AFER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: = 50MMHG, LOSS OF CONSCIOUSNESS AND SHOCK WERE OCCURRED AGAIN. AFTER THE ONSET OF THER AES, OXYGEN 3L AND PHYSIOLOGICAL SALINE 450ML WERE ADMINISTERED. WHILE THE PATIENT WAITING HIS RECOVERY, VOMITING AND CHILLS OCCURRED. AFTER THE BLOOD PRESSURE RETURNED TO 130/70MMHG PATIENT WENT BACK TO HOME. ON (B)(6) 2006, THE DIALYZER (APS-15UA) WAS USED FOR HEMODIALYSIS. TEN MINUTES AFTER STATUS OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: = 50MMHG), LOSS OF CONSCIOUSNESS AND SHOCK WERE OCCURRED. AFTER THE ONSET OF THESE AES, OXYGEN 3 L AND PHYSIOLOGICAL SALINE 450 ML WERE ADMINISTERED. WHILE THE PATIENT WAITING HIS RECOVERY, VOMITING AND CHILLS OCCURRED. AFTER THE BLOOD PRESSURE RETURNED TO 130/70MMHG PATIENT WENT BACK TO HOME. ON (B)(6) 2006, PATIENT WAS TREATED BY DIFFERENT BRAND OF DIALYZER WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89291 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15UA P61L1S

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening CALTAN (PRECIPITATED CALCIUM CARBONATE) 3.6| ONEALFA ALFACALCIDOL 0.25UGX6T| ALOSITOL (ALLOPURINOL) 100MGX3T| PANALDINE (TICLOPIDINE HYDROCHLORIDE) 100MGX1T