BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLIRANS C121

    MDR report key: 15098 · Received February 4, 1994

    Report

    Report Number
    15098
    Event Type
    Other
    Date Received
    February 4, 1994
    Date of Event
    November 6, 1993
    Report Date
    December 23, 1993
    Manufacturer
    TERUMO CORP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    15 MINUTES AFTER INITIATION OF THE TREATMENT, THE PATIENT COMPLAINED OF SOB AND WHEEZING. HIS BLOOD PRESSURE WENT UP TO 240/120. THE TREATMENT WAS DISCONTINUED ON THIS DIALYZER AND RESTARTED ON A FRESENIUS F6. THE PATIENT HAD NO FURTHER PROBLEMS. THIS WAS THE PATIENT'S 1ST TREATMENT IN-CENTER. HE HAD BEEN ON A FOCUS 90. FOCUS 120 AND C121 AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIRANS C121 HOLLOW FIBER HEMODIALYZER TERUMO CORP CLIRANS C121 8893 H 203

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other COBE CENTURY 2 DIALYSIS MACHINE