BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON JR., SIGNATURE

    MDR report key: 578521 · Received February 24, 2005

    Report

    Report Number
    578521
    Event Type
    Other
    Date Received
    February 24, 2005
    Date of Event
    February 10, 2005
    Report Date
    February 23, 2005
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE QUALITY CONTROLS REQUIRED BEFORE USE OF THE HEMOCHRON JR. AND THE NUMBERS OBTAINED WERE APPROPRIATE. SUBSEQUENTLY, THE HEMOCHRON JR WAS USED TO OBTAIN AN ACTIVATED CLOTTING TIME, ACT, ON A PATIENT UNDERGOING AN ANGIOPLASTY. PATIENT WAS GIVEN 2000 UNITS OF HEPARIN AND DEVICE DISPLAYED AN ACT = 152. TWENTY-FIVE MINUTES LATER, THE PATIENT WAS GIVEN ANOTHER 1000 UNITS OF HEPARIN AND DEVICE DISPLAYED ACT = 152. AFTER 20 MINUTES, ANOTHER 1000 UNITS OF HEPARIN WERE GIVEN TO THE PATIENT AND THE ACT OBTAINED WAS 169. THE ANESTHESIOLOGIST WHO WAS MONITORING THE PATIENT REPORTS THAT AFTER 4000 UNITS OF HEPARIN, THE PATIENT'S ACT SHOULD HAVE BEEN APPROXIMATELY 200. A PTT, PROTHROMBIN TIME, REQUESTED FROM LAB AT THE SAME TIME WAS GREATER THAN 106 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR., SIGNATURE COAGULATION ANALYZER, POINT OF CARE JPA INTERNATIONAL TECHNIDYNE CORP. SIGNATURE *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR