BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REXEED SX/LX DIALYZERS

    MDR report key: 4223570 · Received October 30, 2014

    Report

    Report Number
    3007340888-2014-00010
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 16, 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."

    Description of Event or Problem · 1

    ON (B)(6) 2014: 05MIN AFTER START OF TREATMENT WITH REXEED-21LX, PT COMPLAINED RESPIRATORY DIFFICULTY. COLLAPSE APPEARED, ARTERIAL PRESSURE DROPPED FROM 130/80MMHG TO THE POINT NOT POSSIBLE TO MEASURE. ADMINISTRATION: 60ML OF GLUCOSE 20%, 120MG OF PREDNISOLONE. ICU DOCTOR INVITED JUST IN CASE BUT NO VENTILATION WAS APPLIED. RELIEF AFTER DISCONNECTION. ON (B)(6) 2014: SECOND SESSION WITH REXEED-21LX. NON-STABLE HEMODYNAMICS. ON (B)(6) 2014: SWITCH OF DIALYZER TO REXEED-21AX. WITHIN THIS SESSION ARTERIAL PRESSURE DROPPED BELOW 80MMHG. 60MG OF PREDNISOLONE WAS ADMINISTERED. DIALYSIS SESSION WAS TERMINATED. IMMEDIATE RELIEF AFTER DISCONNECTION. (REPORTED AS 3007340888-2014-00020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696247 ASAHI REXEED SX/LX DIALYZERS DIALYZER, HIGH PERMEABILITY KDI ASAHI KASEI MEDICAL CO., LTD REXEED-21LX 9A8Y8M

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DIALYSIS MACHINE: GAMBRO INNOVA