BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    MDR report key: 3775828 · Received April 18, 2014

    Report

    Report Number
    2248721-2014-00014
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 19, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUVETTE LOT# H3JAC328. METHOD: NO RELATED NCRS WERE IDENTIFIED FOR THIS INSTRUMENT. CUVETTE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS. RESULT: THE COMPLAINT WAS NOT CONFIRMED THROUGH THE INSTRUMENT EVAL. CONCLUSION: ITC ADVISED THE HEALTHCARE FACILITY THAT THE ACT+ SAY WAS NOT APPROPRIATE FOR THE HEPARIN CONCENTRATION REQUIRED FOR THIS PROCEDURE. THE PT'S BLOOD HEPARIN CONCENTRATION WAS BELOW THE SENSITIVITY LIMITS LISTED IN THE ACT+ PACKAGE INSERT. ITC RECOMMENDED USE OF THE ACT-LR ASSAY FOR FUTURE PROCEDURES WHERE SIMILAR HEPARIN CONCENTRATIONS ARE USED AS IT WOULD PROVIDE THE NEEDED SENSITIVITY RANGE FOR THE HEPARIN CONCENTRATION. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN EXPECTED ACT+ RESULTS WERE GENERATED WITH THE HEMOCHRON JR. SIGNATURE PLUS MICROCOAGULATION SYSTEM DURING AN EMBOLECTOMY AND STENT RECONSTRUCTION OF THE PT'S INTRACRANIAL CAROTID ARTERY. THE THERAPEUTIC TARGET TIME FOR THE PROCEDURE WAS >200S. PT WAS ADMINISTERED AN INITIAL HEPARIN BOLUS OF 3,000 UNITS AND AN ADDITIONAL 1,000 UNITS WAS ADMINISTERED LATER IN THE PROCEDURE. THE PT'S ACT+ RESULTS REPORTED THROUGHOUT THE PROCEDURE MEASURED BELOW 200S, WHICH IS CONSIDERED SUBTHERAPEUTIC. POSTOPERATIVELY, THE PT'S PARTIAL THROMBOPLASTIN TIME (PTT) FROM THE HOSPITAL LAB WAS OUT OF RANGE WITH A RESULT OF > 300S AND ONE HOUR LATER THE PTT RESULT WAS 225.2S. THE PT SUSTAINED A DELAYED SUBARACHNOID HEMORRHAGE POST-PROCEDURE DUE TO SUPRATHERAPEUTIC ANTICOAGULATION. THIS RESULTED IN THE NEED FOR ADDITIONAL MEDICAL INTERVENTION INCLUDING A VENTRICULOPERITONEAL SHUNT. ALTHOUGH REQUESTED, NO FURTHER DETAILS REGARDING THE PT STATUS HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238669 HEMOCHRON JR. SIGNATURE PLUS SYSTEM IN VITRO COAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. PSIG

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R LIDOCAINE 1% 5MLS| ROBINUL 0.4MG| ANCEF 1G| ZOFRAN 4MG