BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE

    MDR report key: 1039596 · Received May 9, 2008

    Report

    Report Number
    2027791-2008-00005
    Event Type
    Other
    Date Received
    May 9, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 7, 2008
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    NZW
    PMA / PMN Number
    K023740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXCELSIOR MEDICAL IS WORKING TO GATHER FURTHER DETAILS FROM THE COMPLAINANT AND IS ATTEMPTING TO SECURE THE SUSPECT DEVICE(S) FOR INSPECTION. WE HAVE OPENED AN OFFICIAL COMPLAINT AT OUR FACILITY THAT COMBINES BOTH ADVERSE EVENTS FROM REPORTS 2027791-2008-00004 AND 00005. PRIOR TO THESE TWO INCIDENTS, EXCELSIOR FILED TWO SEPARATE MDRS CONCERNING HEPARIN ADVERSE EVENTS, #'S 2027791-2008-00001 AND 2027791-2008-00003. ASIDE FROM THE EVENTS NOTED IN THE AFOREMENTIONED MDRS, A REVIEW OF COMPLAINTS RECEIVED OVER THE PAST TWO YEARS HAS NOT REVEALED ANY OTHER HEPARIN RELATED INCIDENTS. TO DATE, EXCELSIOR HAS ATTEMPTED TO CONTACT THE COMPLAINANT AND THE PHYSICIAN REFERENCED BY HER. DESPITE REPEATED ATTEMPTS, NEITHER OF THEM COULD BE REACHED AT THE TIME THIS MDR WAS FILED. NEVERTHELESS, WE ARE FILING THIS MDR WITH THE CURRENTLY AVAILABLE INFORMATION IN ACCORDANCE WITH THE FDA'S 5 DAY REPORTING REQUIREMENT FOR ADVERSE EVENTS ASSOCIATED WITH HEPARIN-CONTAINING PRODUCTS. WE ARE CURRENTLY IN THE PROCESS OF GATHERING MORE INFORMATION AND ADDITIONAL DETAILS WILL BE GIVEN AS SOON AS RELEVANT DATA IS AVAILABLE.

    Description of Event or Problem · 1

    TWO SEPARATE ADVERSE EVENTS WERE REPORTED TO EXCELSIOR MEDICAL IN A SINGLE EMAIL IN 2008 BY AN RN WHO WAS ADMINISTERING OUR PRODUCT IN A HOME SETTING. BOTH EVENTS AFFECTED THE SAME PATIENT. THE FIRST EVENT WAS HANDLED UNDER REPORT 2027791-2008-00004. THE SECOND EVENT WILL BE DETAILED IN THIS MDR. THE SECOND EVENT OCCURRED ON THE PREVIOUS MONTH. WITHIN 1 MINUTE OF GIVING THE FLUSH, THE PATIENT WENT INTO DISTRESS. HIS OXYGEN DROPPED TO 83% ON ROOM AIR, FACE BLUE GREY, HIS PULSE WAS ABOUT 120 AND HIS BP AS NORMAL. PARAMEDICS ARRIVED AT THE PATIENTS' HOME. HE WAS VERY AGITATED AT THIS TIME BUT SEEMED "OK" ENOUGH TO STAY AT HOME, AS EVALUATED BY THE PARAMEDICS AND AT THE PATIENTS' DISCRETION. AT NURSE'S URGING, PATIENT WENT TO THE HOSPITAL THE FOLLOWING MORNING FOR EVALUATION. PATIENT FOUND TO BE IN SEPTIC SHOCK. HAD FEVER UP TO 104 DURING THE PREVIOUS NIGHT, HAD A BP OF 67/37 THAT MORNING, HEART RATE OF 137 AND WBC COUNT OF 55K. NURSE BELIEVES INFECTION IN BLOODSTREAM WAS SERRATIA MARCESCENS. SUBSEQUENTLY, 10 DAYS WERE SPENT IN ICU AND PATIENT RELEASED ON TWO DAYS PRIOR TO ORIGINAL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PRE-FILLED HEPARIN LOCK FLUSH SYRINGE 100 U/ML HEPARIN LOCK FLUSH SYRINGE NZW EXCELSIOR MEDICAL CORP. NA 12-015-DS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| O FLUSH. ALTHOUGH RN DID NOT SPECIFY WHAT| PRECISELY| INSTILLED 100 BNS BEFORE LOCKING WITH HEPARIN| "BULK NORMAL SALINE".