BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REXEED SX/LX DIALYZERS

    MDR report key: 4223597 · Received October 30, 2014

    Report

    Report Number
    3007340888-2014-00030
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ASAHI KASEI MEDICAL CO., LTD
    Product Code
    KDI
    PMA / PMN Number
    K121409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. 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 LES SWELL DEFINED ADVERSE REACTIONS OF UNK CAUSE. "HANDBOOK OF DIALYSIS 4TH EDITION." THIS IS 2ND SAE FOR SAME LOT# OF REXEED-21LX AND 3RD SAE FOR REXEED-SX/LX DIALYZER MODEL IN SAME SITE. SO, WE SENT OUR EMPLOYEE WITH MEDICAL LICENCE TO THE SITE FOR HEARING. DR. (B)(6), CHIEF OF DIALYSIS UNIT, CONSIDERS THIS CASE MOSTLY AS INDIVIDUAL REACTION TO DIALYZER MEMBRANE, NOT TO SPECIFIC LOT OF PRODUCTS. THEY USE ENOUGH VOLUME OF SALINE FOR PRIMING AND ANY OTHER WRONG CONDUCT IN THE SITE WAS NOT FOUND. WE WILL KEEP ON WATCHING THE AE OF THIS MODEL WORLDWIDE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014: PT HAD SOME COMPLICATIONS LIKE ARTERIAL PRESSURE DROP, BREATHLESSNESS BUT THEY COMPLETED THE TREATMENT. ON (B)(6) 2014: 5MIN AFTER START OF TREATMENT, ARTERIAL PRESSURE DROPPED FROM 130/80MMHG TO 80/45MMHG, RESPIRATORY AFFECTION, CHEST PAIN, CHIL (BODY TEMPERATURE 37.6 C), SIGNS OF MYOCARDIAL ISCHEMIA IN ECG. DIALYSIS SESSION HAS BEEN TERMINATED, PREDNISOLONE ADMINISTERED. QUICK RELIEF WITH 30MINS; NORMALIZATION OF ECG ON THE NEXT DAY. ON (B)(6) 2014: AFTER SWITCH TO POLYFLUX-21H, DIALYSIS WAS CONDUCTED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696823 ASAHI REXEED SX/LX DIALYZERS DIALYZER, HIGH PERMEABILITY KDI ASAHI KASEI MEDICAL CO., LTD REXEED-21LX 9A8Y8M

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DIALYSIS MACHINE: GAMBRO INNOVA