BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 5679968 · Received May 25, 2016

    Report

    Report Number
    3002721930-2016-00006
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 28, 2016
    Report Date
    August 5, 2016
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K941007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION WAS PERFORMED. DHR REVIEWED SHOWED NO NCRS, CAPAS, INSTRUMENT REPAIRS OR OTHER ANOMALIES RELATED TO THIS COMPLAINT. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE NOT RETURNED. ACCRIVA HAS REQUESTED ALL DATA REQUIRED FOR FORM FDA 3500A.

    Additional Manufacturer Narrative · 1

    THIS MDR FOLLOW-UP #1 SUBMITTED ON 08/04/2016 SUMMARIZES THE RESULTS UNDER INVESTIGATION LSR 2016-CSS-056, WHICH TESTED RETAILED SAMPLES FROM THE SAME JACT+ CUVETTE LOT (J5JAC611) NAMED IN THE CHILD CASE. THIS REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) (PARENT CASE (B)(6)) SUBMITTED ON (B)(6) 2016 FOR THE HEMOCHRON SIGNATURE ELITE INSTRUMENT (SERIAL NUMBER (B)(4)). ADDITIONAL INFORMATION: MODEL JACT+; CATALOG # JACT+; EXPIRATION DATE 12/31/2016. DEVICE AVAILABLE FOR EVALUATION? YES. DATE RECEIVED BY MANUFACTURER 06/23/2016. PMA PMA/510(K) K941007. TYPE OF REPORT: FOLLOW-UP #1. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE MANUFACTURING DATE 09/17/2015. LABELED FOR SINGLE USE? YES. INITIAL USE OF DEVICE? YES. METHOD CODE: RESERVE SAMPLES TESTED FROM SAME LOT, NO FAILURE DETECTED. RESULTS CODE: NO FAILURE DETECTED. CONCLUSION CODE: UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED OUT OF RANGE HIGH READINGS WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. AN UNIDENTIFIED (B)(6) YEAR-OLD MALE WEIGHING (B)(6)RECEIVED A 330 UNIT/KG INTRAVENOUS BOLUS DOSE OF HEPARIN PRIOR TO THE START OF A CORONARY ARTERY BYPASS GRAFT PROCEDURE. THE TARGET ACT WAS 480 TO 500 SECONDS. THE ACT RESULTS REPORTED WITH THE HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR THAT WAS RECORDED MIDWAY THROUGH THE OPERATION. THERE WAS NO REPORT OF ADDITIONAL HEPARIN DOSES ADMINISTERED. THE INSTRUMENT PASSED BOTH ELECTRONIC AND LIQUID QUALITY CONTROLS PRIOR TO THE PROCEDURE ACCORDING TO THE END USER.

    Description of Event or Problem · 1

    FOLLOW-UP #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334372 HEMOCHRON SIGNATURE ELITE SYSTEM, IN-VITRO MICROCOAGULATION JPA ACCRIVA DIAGNOSTICS JACT+ J5JAC611

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR