BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON

    MDR report key: 137602 · Received December 5, 1997

    Report

    Report Number
    137602
    Event Type
    Other
    Date Received
    December 5, 1997
    Date of Event
    November 16, 1997
    Report Date
    November 25, 1997
    Manufacturer
    ITC (INTERNATIONL TECHIDYNE CORP.)
    Product Code
    JBP
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEMOCHRON JR-USED TO ADJUST HEPARIN WITH ACT SCALE. ADJUSTMENTS OF HEPARIN MADE PER READ OUTS OF HEMOCHRON. PT DEVELOPED NOSE BLEED AND BLEEDING FROM PENIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON HEMODIALYSIS MACHINE JBP ITC (INTERNATIONL TECHIDYNE CORP.) SR-1913 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other