BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMUKIN-D

    MDR report key: 269418 · Received March 9, 2000

    Report

    Report Number
    8021034-1999-00005
    Event Type
    Other
    Date Received
    March 9, 2000
    Date of Event
    May 17, 1999
    Report Date
    May 17, 1999
    Manufacturer
    AMUCHINA S.P.A.
    Product Code
    LRJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE MINS INTO THE DIALYSIS PROCEDURE, THE PT EXPERIENCED SHORTNESS OF BREATH AND TIGHTNESS IN THE CHEST. THE BLOOD PRESSURE INCREASED FROM 170/97 TO 244/137.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMUKIN-D DISINFECTANT FOR REPROCESSING LRJ AMUCHINA S.P.A. NA 5041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PT WAS TAKING DIFFERENT MEDICATIONS, ESPECIALLY AN| ACE INHIBITOR.