BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIACIDE DIALYZER

    MDR report key: 349262 · Received August 28, 2001

    Report

    Report Number
    1221361-2001-00004
    Event Type
    Injury
    Date Received
    August 28, 2001
    Date of Event
    July 25, 2001
    Report Date
    July 26, 2001
    Manufacturer
    ALDEN, A DIVISION OF METREX RESEARCH CORPORATION
    Product Code
    FKQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR FROM THE FACILITY REPORTED THAT UPON THE ONSET OF DIALYSIS A PT EXPERIENCED LOW BLOOD PRESSURE, SHORTNESS OF BREATH, AND PERIORAL NUMBNESS. THE CLINICIAN DISCONTINUED DIALYSIS UPON NOTICING THE REACTIONS. THE PT REC'D MEDICAL ATTENTION AND WAS PRESCRIBED DOPAMINE. THE PT'S BLOOD PRESSURE RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39140 DIACIDE DIALYZER DISINFECTANT FOR DIALYZERS FKQ ALDEN, A DIVISION OF METREX RESEARCH CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R