BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSN DIALYZER (PSN 170)

    MDR report key: 388736 · Received April 15, 2002

    Report

    Report Number
    1423500-2002-00461
    Event Type
    Other
    Date Received
    April 15, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 20, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTS THREE INCIDENTS OF PT REACTIONS WITH THE PSN 210 DIALYZER FOR THE SAME PT. ON ONE OCCASSION UPON INITIATION OF TREATMENT, THE PT EXPERIENCED BACK PAIN, CHEST PAIN, AND RIGHT ARM PAIN. TREATMENT WAS DISCONTINUED AND BLOOD WAS RETURNED TO THE PT. THE PT WAS ADMINISTERED BENADRYL (DOSE AND ROUTE UNKNOWN). ON A SECOND OCCASION, UPON INITIATION OF TREATMENT, THE PT EXPERIENCED BACK PAIN, CHEST PAIN, RIGHT ARM PAIN, AND HYPERTENSION (BLOOD PRESSURE = 230/115). TREATMENT WAS STOPPED, BLOOD WAS RETURNED TO THE PT AND THE DIALYZER WAS FLUSHED WITH 5 L NS. TREATMENT WAS RESUMED WITH THE SAME DIALYZER AND THE PT AGAIN EXPERIENCED BACK PAIN, CHEST PAIN, AND RIGHT ARM PAIN. TREATMENT WAS STOPPED AND BLOOD WAS RETURNED TO THE PT. TREATMENT WAS DISCONTINUED AND PT WAS ADMINISTERED NITROGLYCERINE SUBLINGUALLY (DOSE AND ROUTE UNKNOWN), CLONIDINE (DOSE AND ROUTE UNKNOWN), AND A CATAPRES PATCH (DOSE UNKNOWN). ON A THIRD OCCASSION, UPON INITIATION OF TREATMENT, THE PT EXPERIENCED BACK PAIN, CHEST PAIN AND HYPERTENSION. TREATMENT WAS STOPPED AND BLOOD WAS RETURNED TO THE PT. THE PT WAS ADMINISTERED ZESTRIL (DOSE AND ROUTE UNKNOWN), CLONIDINE (DOSE AND ROUTE UNKNOWN), AND A CATAPRES PATCH (DOSE UNKNOWN). HCP REPORTED THAT THE PT IS EXPERIENCING SOME EDEMA AND WHEEZING BUT FEELS IT IS ATTRIBUTED TO FLUID RETENSION AS THE PT HAS NOT BEEN ADEQUATELY DIALYZED. IT WAS ALSO REPORTED THAT THE PT HAD UNDERGONE CONTINUOUS RENAL REPLACEMENT THERAPY USING A MEMBRANE OF A DIFFERENT TYPE AND EXPERIENCED SIMILAR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSN DIALYZER (PSN 170) HOLLOW FIBER DIALYZER FJI BAXTER HEALTHCARE CORP. PSN 170 H02A18065

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other