BEUDAMED
    FDA Adverse Event Other Summary report: N

    CA-HP DIALYZER (CA-HP 210)

    MDR report key: 298314 · Received September 28, 2000

    Report

    Report Number
    1423500-2000-01011
    Event Type
    Other
    Date Received
    September 28, 2000
    Date of Event
    September 5, 2000
    Report Date
    September 7, 2000
    Manufacturer
    NISSHO CORP
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTS A PT REACTION ON THE 6TH USE OF THE MEMBRANE DURING PT TREATMENT WHILE USING THE CA-HP 210 DIALYZER. PT HAD BEEN DIALYZING WITH THIS TYPE OF DIALYZER SINCE JUNE 26, 2000. THE HCP REPORTS THAT THE PT WAS NOTED TO HAVE SKIN FLAKING, REDNESS, RASH AND ITCHING. THESE SYMPTOMS HAD BEEN PRESENT FOR APPROXIMATELY 1 WEEK PRIOR TO THE REPORTED INCIDENT, HOWEVER, BECAME SEVERE DURING DIALYSIS TREATMENT (TX) AT THIS TIME THE DIALYSIS TX WAS DISCONTINUED AND THE PT WAS TREATED WITH BENADRYL 25MG, ORALLY AND BENADRYL 25MG, INTRAVENOUSLY WITH NO RELIEF. THE HCP THEN APPLIED LUBRIDERM TO THE PT'S SKIN AND 15 MINUTES LATER THE PT REPORTED RELIEF FROM SYMPTOMS. PER THE HCP, PT'S SYMPTOMS HAVE RESOLVED. PT WAS DIALYZED ON 09/07/00 WITH AN ALTERNATE MEMBRANE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP DIALYZER (CA-HP 210) HOLLOW FIBER DIALYZER FJI NISSHO CORP CA-HP 210 E00C27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other RENATRON.