BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON SIGNATURE INSTRUMENT / ACT-LR ASSAY

    MDR report key: 1312409 · Received February 10, 2009

    Report

    Report Number
    2248721-2009-00042
    Event Type
    Other
    Date Received
    February 10, 2009
    Report Date
    February 10, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JBP
    PMA / PMN Number
    K960749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO RECENT RECEIPT OF INFO BY ITC CLARIFYING REPORTING RULES WHERE BOTH MULTIPLE PTS AND MULTIPLE DEVICES ARE INVOLVED. IN ACCORDANCE WITH THAT INFO, THIS F/U REPORT CLARIFIES THE PT - ADVERSE EVENT RELATIONSHIP AS OPPOSED TO PRIOR REPORTS WHICH NOTED THE DEVICE - ADVERSE EVENT RELATIONSHIP. IN A TELECONFERENCE WITH THE MEDICAL DIRECTOR ON (B)(6) 2008, THE MEDICAL DIRECTOR CONCLUDED THAT FACILITY WILL NOT RETURN PRODUCT FOR ITC EVAL AS: CORRELATION STUDIES PERFORMED BY THE FACILITY SHOW ACCEPTABLE PERFORMANCE OF THE SUBJECT HEMOCHRON SYSTEM. HEMOCHRON SYSTEMS IN PLACE AT OTHER AREAS OF THE HOSPITAL ARE PERFORMING WELL. FACILITY BELIEVES THE SUBJECT HEMOCHRON SYSTEM IS OPERATING CORRECTLY. THE SUBJECT HEMOCHRON SYSTEM CONTINUES TO BE USED WITHOUT ISSUE IN FACILITY. WHILE NOT PROVEN TO BE DIRECTLY CORRELATED TO THE SUBJECT EVENTS, PPT DRUG TREATMENT THERAPY FOR NEONATES ON ECMO WITH DIAPHRAGMATIC HERNIAS HAS BEEN ALTERED. FACILITY HAS BEEN REQUESTED TO PROVIDE IN-HOUSE CORRELATION STUDY DATA TO MFR.

    Description of Event or Problem · 1

    OVER APPROX 12 MONTHS PERIOD, 6 PTS IN FACILITY NEONATE UNIT EXPERIENCED CRANIAL BLEED FOR UNDETERMINED REASONS. PTS ARE CATEGORIZED BY FACILITY AS HIGH-RISK, ON ECMO, WITH DIAPHRAGMATIC HERNIAS. FACILITY INVESTIGATION CONCLUDED HEMOCHRON SIGNATURE/ACT-LR SYSTEM NOT CAUSAL AND HAS ALTERED DRUG TREATMENT THERAPY PRACTICES. THIS REPORT IS FOR PT 6 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE INSTRUMENT / ACT-LR ASSAY HEMOCHRON SIGNATURE ACT-LR JBP INTERNATIONAL TECHNIDYNE CORP. HE-SIG ASSAY/UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other