BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 162906 · Received April 14, 1998

    Report

    Report Number
    1423500-1998-01229
    Event Type
    Injury
    Date Received
    April 14, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 17, 1998
    Manufacturer
    NISSHO
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTH CARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 2

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTH CARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 3

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTH CARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 4

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTH CARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 5

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTHCARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 6

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTHCARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 7

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTHCARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Description of Event or Problem · 8

    HEALTH CARE PROFESSIONAL REPORTS 8 PTS REPORTED ONE OR MORE OF THE FOLLOWING SYMPTOMS ABOUT ONE HOUR INTO TREATMENT: NAUSEA, VOMITING, LOW BLOOD PRESSURE, DIARRHEA, RED CHEEKS, AND BLOOD SHOT EYES. ALL PATIENTS EXPERIENCED THE PREVIOUSLY MENTIONED SYMPTOMS AFTER THE 34TH REUSE OF THE DIALYZER. THE HEALTHCARE PROFESSIONAL REPORTS THE MAXIMUM REUSE NUMBER OF THE DIALYZERS WERE RECENTLY INCREASED FROM 35 TO 45. THE HEALTH CARE PROFESSIONAL REPORTS 2 PTS RECEIVED BENADRYL FOR RELIEF OF SYMPTOMS, THE OTHER 6 PTS REQUIRED NO MEDICAL INTERVENTION. NO HOSPITALIZATION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NISSHO CT190G NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 UNKNOWN
    3 UNKNOWN
    4 UNKNOWN
    5 UNKNOWN
    6 UNKNOWN
    7 UNKNOWN
    8 UNKNOWN