BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON

    MDR report key: 484873 · Received July 25, 2003

    Report

    Report Number
    484873
    Event Type
    Injury
    Date Received
    July 25, 2003
    Date of Event
    December 20, 2002
    Report Date
    July 25, 2003
    Manufacturer
    HORIZON MEDICAL PRODUCTS
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH END STAGE RENAL DISEASE SECONDARY TO HYPERTENSIVE NEPHROPATHY. PT UNDERWENT THEIR FIRST HEMODIALYSIS IN 1996. PT WAS ADMITTED TO THIS FACILITY IN 1996. PT WAS KNOWN TO HAVE CONGESTIVE HEART FAILURE IN THE PAST, WITH RIGHT-SIDED PLEURAL EFFUSION. ECHOCARDIOGRAM ALSO REVEALED LEFT VENTRICULAR HYPERTROPHY. PT DEVELOPED BILATERAL ANEURYSMS OF THE GRAFT. GRAFT WAS NOT WORKING WELL. DOCTOR HAD SEVERAL DISCUSSIONS WITH PT. PT WANTED TO HAVE PERM CATHETER PLACED. THIS WAS DONE IN 2002. SIX DAYS LATER PT UNDERWENT EXCLUSION BYPASS OF THE ANEURYSM AND THE OLD GRAFT COULD NOT BE SALVAGED. PT WISHED TO CONTINUE USING PERM CATHETER AS LONG AS POSSIBLE. PT DID NOT WISH DOCTOR TO TAKE THE CATHETER OUT AND USE THE GRAFT IN COUPLE OF MONTHS. PT STATED THAT THEY WERE TIRED OF BEING PUNCTURED THREE TIMES A WEEK. SINCE PT'S SPOUSE DIED, PT WAS ALSO MORE DEPRESSED. PT RECENTLY UNDERWENT UPPER LIP SURGERY IN 2002. FOLLOWING SURGERY, DOCTOR DROPPED PT'S DRY WEIGHT BECAUSE OF SOME LEG EDEMA AND SHORTNESS OF BREATH CONSISTENT WITH CONGESTIVE HEART FAILURE. PT IMPROVED SOME AFTER DOING THAT. IN 2002, DOCTOR RECEIVED A BEEP TO CALL UNIT STAT. PT WAS UNDERGOING CPR. APPARENTLY AROUND 9:24 A.M. THERE WAS A SMALL DROP OF BLOOD ON THE CHEST WALL AT THE INSERTION SITE. BOTH STAFF MEMBERS LOOKED AT THE LINES AND CHECKED THE LINES, AND THERE WAS NO EVIDENCE OF ACTIVE BLEEDING. AROUND 9:27 IN THE MORNING, WHILE STAFF MEMBER WAS RINSING ANOTHER PT, THEY HEARD A GASP AND LOOKED OVER AT PT. PT APPEARED ASHEN AND WAS STARING STRAIGHT AHEAD. THEY IMMEDIATELY RAN OVER AND PLACED HAND ON THE PERM CATHETER BECAUSE THEY THOUGHT THAT PERM CATHETER WAS LEAKING. THE VENOUS END OF THE BLOOD LINE BECAME DISCONNECTED. THERE WAS NO AIR IN THE SYSTEM. THE ARTERIAL CONNECTION WAS INTACT. THEREFORE, AIR EMBOLISM WAS HIGHLY UNLIKELY, BECAUSE THE LINES WERE FULL OF BLOOD AND BLOOD WAS COMING OUT OF THE VENOUS END OF THE CATHETER. CPR WAS INITIATED . PT WAS IN ASYSTOLE. PARAMEDICS CAME AND TOOK PT TO HOSPITAL. CODE WAS DONE FOR APPROX 15 MINUTES. THERE WAS NO ELECTRICAL ACTIVITY IN THE BEGINNING, AND PT HAD TRANSIENT ELECTRICAL ACTIVITY, BUT NO BLOOD PRESSURE WITH IT. IN THE DIALYSIS UNIT PT RECEIVED AT LEAST ONE LITER OF SALINE. AFTER PT WENT TO HOSPITAL PT RECEIVED SOME MORE FLUIDS, EPINEPHRINE, ATROPINE AND BICARBONATE. PT'S HEMOGLOBIN THERE WAS NOTED TO BE 8.3, AND HEMATOCRIT 25% AFTER VOLUME EXPANSION DURING THE CPR. PT DID NOT RESPOND TO FLUID RESUSCITATION LIKE PT SHOULD IF PT HAD NO BLOOD PRESSURE FROM BLOOD LOSS. MOREOVER, NURSES APPROXIMATED THE BLOOD LOSS TO BE ONLY 300CC. EVEN IF IT WAS MORE THAN THAT, SALINE ADMINISTRATION SHOULD HAVE BROUGHT THE BLOOD PRESSURE BACK, IF THAT WAS THE CAUSE. DR STATED THAT SHE NOTICED ELEVATION OF ST SEGMENTS DURING THE CODE. SHE FELT THAT PT SUSTAINED MASSIVE ACUTE MYOCARDIAL INFARCTION RESULTING IN ASYSTOLE. BASED ON THE SCENARIO AND BASED ON INFO FROM DR DURING THE CODE, DOCTOR CONCURRED WITH DR THAT PT PROBABLY SUSTAINED MASSIVE MYOCARDIAL INFARCTION CAUSING ASYSTOLE. IT WAS ALSO FEASIBLE THAT AFTER PT SUSTAINED MYOCARDIAL INFARCTION AND WHEN PT DEVELOPED A BIG GASP, THAT WOULD RESULT IN MOVEMENT OF THE NECK, WHICH COULD HAVE RESULTED IN SEPARATION OF THE VENOUS LINE FROM THE CATHETER. CAUSE OF DEATH: ACUTE MYOCARDIAL INFARCTION WITH ASYSTOLE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM 03/16/04: HORIZON WAS FIRST NOTIFED OF THE INCIDENT IN MAY 2003 WHEN THE LAWSUIT WAS FILED. AFTER THE LAWSUIT WAS FILED, HORIZON MADE A DILIGENT EFFORT TO REMOVE AND OBTAIN THE HORIZON CATHETER FOR TESTING AND ANALYSIS. HOWEVER, NO PARTICIPANT TO THE LITIGATION, OR ANY OTHER PARTY CONTACTED BY HORIZON OR ITS LEGAL COUNSEL DURING THE LITIGATION, HAS BEEN ABLE TO LOCATE THE HORIZON CATHETER. AS A RESULT, HORIZON HAS BEEN DENIED THE OPPORTUNITY TO PERFORM ANY FAILURE ANALYSIS OR LABORATORY TESTING ON ITS CATHETER PRODUCT. LEGAL COUNSEL FOR HORIZON AND EXPERT WITNESSES FOR HORIZON IN THE LITIGATION HAVE ATTEMPTED TO DETERMINE WHETHER OR NOT THE HORIZON CATHETER SUFFERED ANY PRE-INCIDENT PROBLEMS AND/OR WHETHER THE HORIZON CATHETER WAS THE CAUSE OF OR CONTRIBUTED TO THE INCIDENT AT ISSUE. GIVEN THAT THE HORIZON CATHETER HAS NOT BEEN AVAILABLE TO HORIZON FOR TESTING AND ANALYSIS, AND IN VIEW OF THE DEPOSITION TESTIMONY OF THE WITNESSES WHO SAW THE DISCONNECT EVENT, IT IS THE OPINION OF HORIZON THAT ITS DEVICE DID NOT IN ANY WAY CAUSE OR CONTRIBUTE TO THE INCIDENT AT ISSUE. LAWYERS FOR THE FAMILY OF THE DECEDENT OBTAINED AN AUTOPSY. THE AUTOPSY CONCLUDES THAT THE DEATH WAS CAUSED BY HYPOVOLEMIC SHOCK, SECONDARY TO BLOOD LOSS. HORIZON, HOWEVER, DISPUTES THIS FINDING BECAUSE A) BLOOD VOLUME WAS NEVER MEASURED AND THE BODY WAS EMBALMED PRIOR TO THE AUTOPSY; B) THE DECEDENT SUFFERED FROM SIGNIFICANT HEART PROBLEMS, INCLUDING ONE 100% ARTERIAL BLOCKAGE AND ONE 60% VENOUS BLOCKAGE, AND C) THE TREATING PHYSICIAN AND HORIZON'S EXPERT PATHLOGIST OPINE THAT THE DECEDENT DIED AS A RESULT OF MYOCARDIAL INFARCTION, AS INDICATED ON THE DEATH CERTIFICATE. HORIZON HAS NOT PROVIDED A COPY OF THE AUTOPSY REPORT, AS IT CONTAINS CONFIDENTIAL, MEDICAL INFO REGARDING THE DECEDENT AND, AS SUCH, THE REPROT MAY BE SUBJECT TO THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT. HORIZON ALSO MAKES REFERENCE TO ITS OWN MDR REPORTING THE INCIDENT (MFR REPORT NO 1056436-2003-00062) THAT WAS FILED WITH THE FDA ON JUNE 2003 AND TWO SUPPLEMENTAL REPORTS TO SUCH MDR FILED ON SEPT 2003 AND NOV 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON PERMANENT CATHETER ACCESS LJT HORIZON MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR