BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE, 110V

    MDR report key: 4911998 · Received July 10, 2015

    Report

    Report Number
    2248721-2015-00057
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K030818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR DATED 07/10/2015 REFERENCES (B)(4). THE LOT NUMBER OF THE RESPONSE CELITE ACT TUBE USED DURING THIS CASE (C5FTE081) IS REFERENCED BY (B)(4). ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LOWER THAN EXPECTED READINGS WITH A HEMOCHRON RESPONSE AND CELITE ACT TUBE SYSTEM. A (B)(6) MALE PATIENT WAS RECEIVING IV HEPARIN IN THE CARDIOVASCULAR OPERATING ROOM DURING AN AORTIC VALVE REPAIR. THE TARGET ACT WAS NOT SPECIFIED. THE HEMOCHRON RESPONSE AND CELITE ACT TUBE SYSTEM REPORTED LOWER THAN EXPECTED RESULTS AFTER HEPARIN WAS ADMINISTERED. A REPEAT BLOOD SAMPLE WAS ASSAYED ON A SECOND HEMOCHRON RESPONSE INSTRUMENT AND THE ACT RESULT WAS AS EXPECTED. THE INSTRUMENT WAS RETURNED TO ITC FOR EVALUATION. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO ADVERSE EVENTS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448425 HEMOCHRON RESPONSE, 110V SYSTEM, IN VITRO MICROAGULATION JPA INTERNATIONAL TECHNIDYNE CORP. HRS.110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR