BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 4100442 · Received September 19, 2014

    Report

    Report Number
    2184009-2014-00069
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    March 28, 2014
    Report Date
    September 24, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTED IN ORDER TO CORRECT THE INITIAL REPORT FROM A REPORTABLE SERIOUS INJURY TO A NON-REPORTABLE EV ENT. EVALUATION OF THIS PRODUCT EVENT INDICATES THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. INFORMATION RECEIVED FROM THE FIELD INDICATES THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS PRODUCT EVENT. ADDITIONALLY, EVALUATION OF THE DEVICE EVENT DATA SHOWED THAT THE DEVICE PERFORMED AS EXPECTED, INDICATING NO MALFUNCTION. ADDITIONALLY, A REVIEW OF PRIOR EVENTS INDICATES THAT, FOR THIS PRODUCT OR SIMILAR PRODUCT, THE PRODUCT EVENT IS NOT SUSPECTED TO HAVE BEEN A CAUSE, OR CONTRIBUTORY CAUSE, OF ANY PREVIOUS INCIDENTS THAT HAVE LED TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION ABOVE, MEDTRONIC CONCLUDED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND THE EVENT WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT INVESTIGATION REMAINS IN PROGRESS AND THE INSTRUMENT REMAINS WITH THE CUSTOMER IN THE FIELD. HOWEVER, PRELIMINARY ANALYSIS PERFORMED IN THE FIELD SHOWED THAT THE DEVICE PERFORMED AS INTENDED. THERE WERE NO PRODUCT ISSUES OR MALFUNCTIONS DETECTED THAT WOULD HAVE IMPACTED THIS EVENT. PATIENT AND DEVICE INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING USE OF THIS HMS PLUS IN A PROCEDURE, THE COAGULATION TEST RESULTS DID NOT MEET THE USER'S EXPECTATIONS AS BLOOD COTS APPEARED ON THE PERICARDIUM. THE USER DOUBTED THE ACCURACY OF THE INSTRUMENT. USE OF THE INSTRUMENT WAS CONTINUED WITH NO RESULTING ADVERSE PATIENT IMPACT. THE INSTRUMENT WAS INSPECTED BY MEDTRONIC FRANCE SERVICE AND REMAINS IN USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DETAILS OF THE EVENT WERE SUMMARIZED AS FOLLOWS: O T=0 NORMAL COAGULATION O BYPASS LASTED 165 MIN AND ACTIVATED CLOTTING TIME (ACT) WAS BETWEEN 430 AND 460 SECONDS DURING THAT TIME. BLOOD CLOTS APPEARED ON THE PERICARDIUM AND THE MEASURE OF ACT WAS 451, ANOTHER MEASURE OF ACT MADE WITH ANOTHER MACHINE AND GAVE ACT OF 456 SEC. O INJECTION OF 19000UI OF HEPARIN AND THE END OF THE PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585116 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening