BEUDAMED
    FDA Adverse Event Summary report: N

    ACT+ CUVETTE

    MDR report key: 4817595 · Received June 1, 2015

    Report

    Report Number
    4817595
    Date Received
    June 1, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS
    Product Code
    JBP
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SITUATION: THE HIGH RANGE ACT+ CUVETTES THAT WE USE WITH THE ACCRIVA HEMOCHRON SIGNATURE ELITE INSTRUMENTS FOR ACTIVATED CLOTTING TIME (ACT) IN PERFUSION HAVE A SERIOUS ISSUE THAT MAY REQUIRE A CHANGE IN METHODOLOGY. BACKGROUND: THE PERFUSIONISTS ARE REPORTING FREQUENT RANDOM ERRORS. IN SOME CUVETTES, THE SAMPLE DOES NOT SEEM TO GENERATE A CLOT, RESULTING IN AN "OUT OF RANGE HIGH", WHICH IS INTERPRETED AS >1005. WHEN NEW SPECIMENS ARE COLLECTED, THE NEW RESULTS DROP DOWN TO THE EXPECTED 450-550 RANGE. ACCRIVA AT FIRST SAID THIS WAS A SAMPLING ISSUE, HOWEVER, PERFUSION WASTES THE PROPER AMOUNT OF BLOOD, AND FURTHER, THEY DRAW SAMPLES FROM A DIFFERENT PORT THAN THE ONE THEY USE TO GIVE HEPARIN. ONE OF THE PERFUSIONISTS SAID THAT SHE HAD SEEN THIS BEFORE MANY TIMES AT OTHER HOSPITALS.ASSESSMENT: AFTER FURTHER INVESTIGATION, I ESTIMATE THAT THIS IS HAPPENING IN APPROXIMATELY 4% OF CUVETTES, ACROSS ALL CUVETTE LOTS, INSTRUMENT SERIAL NUMBERS, AND OPERATORS. I CALLED ACCRIVA TO REPORT THE ISSUE AGAIN AND THEY ARE NOW SAYING IT IS A KNOWN PROBLEM WITH ACT+ AND THEY HAVE ESCALATED OUR CASE. WE HAVE NOT HEARD REPORTS OF THIS FOR THE LOW-RANGE ACT-LR CUVETTE USED IN THE OTHER AREAS. WE ARE COLLECTING WEEKLY DATA FOR ACCRIVA SUCH AS HEPARIN DOSING, WASTE AMOUNTS, AND DRAW SITES.RECOMMENDATION: WE WILL BE SWITCHING METHODOLOGY, AT LEAST TEMPORARILY AND AT LEAST IN PERFUSION (THE ONLY UNIT USING THE ACT+ CUVETTES STAT FOR THOSE HIGH DOSE HEPARIN PROCEDURES). WE WILL BEGIN TRAINING STAFF AND VALIDATING ACT ON ABBOTT I- AS EARLY AS NEXT WEEK. I-STAT HAS AN ACT CARTRIDGE THAT COVERS BOTH THE LOW-DOSE AND HIGH-DOSE HEPARIN RANGES UP TO 1000SEC. OUR ABBOTT REP GAVE A DEMO TO US THE OTHER DAY. WE HAVE FIVE I-STATS CURRENTLY IN THE POCT SYSTEM ALTHOUGH NOT CURRENTLY IN USE. WE DON'T HAVE A RALS MODULE FOR THIS INSTRUMENT SO EVERYTHING FOR COMPLIANCE WILL BE DONE ON PAPER, AT LEAST FOR NOW.MANUFACTURER RESPONSE FOR ACT DEVICE, ACCRIVA (PER SITE REPORTER).======================STILL INVESTIGATING-NEED MORE INPUT FROM US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352751 ACT+ CUVETTE ACTIVATED WHOLE BLOOD CLOTTING TIME JBP ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *