BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 957510 · Received September 1, 2006

    Report

    Report Number
    1713683-2006-00018
    Event Type
    Death
    Date Received
    September 1, 2006
    Date of Event
    July 26, 2006
    Report Date
    August 7, 2006
    Manufacturer
    GAMBRO HEALTH CARE
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ATTACHED FAILURE INVESTIGATION SYSTEMS REPORT NUMBERS 1283773, NOTE: PAR# 56733199 HAS BEEN CANCELED AND REPLACED WITH PAR# 56859699 TO REFLECT THE HEMOLYSIS INCIDENT AGAINST THE SYSTEM AND NOT THE DISPOSABLE SET. NOTE THAT WITH CESSATION OF ALL MFG ACTIVITIES IN DECEMBER 2000, GAMBRO RENAL PRODUCTS IS NO LONGER A MEDICAL DEVICE MFR. INVESTIGATION: A COPY OF THE PT'S TREATMENT SHEET WAS REQUESTED, BUT DENIED BY THE LEGAL COUNSEL FOR DAVITA. NO WRITTEN RECORDS OTHER THAN THE MEDWATCH WAS SUPPLIED FOR THIS INVESTIGATION. THE FACILITY ADMINISTRATOR, CHRISTINE HOLTMEYER, STATED THAT SHE DID NOT RECALL RECEIVING THE SAFETY ALERT SENT OUT BY GAMBRO REGARDING OBSERVING THE DIALYZER LINES FOR KINKS. SHE STATED THAT THIS ALERT WAS SENT TO HER FOLOWING THE INCIDENT. IT WAS CONFIRMED WITH DOUG LUEHMANN, VICE PRESIDENT FOR DAVITA, THAT GAMBRO NOTIFIED DAVITA AND THAT DAVITA TOOK RESPONSIBILITY TO NOTIFY ITS CLINICS OF THE SAFETY ALERT. DOUG STATED THAT THE SAFETY ALERT WAS SENT BY E-MAIL TO EACH FACILITY ADMINISTRATOR. THE FACILITY REPORTS THAT NO MACHINE ALARMS OCCURRED DURING THIS TREATMENT. DAVITA WOULD NOT ALLOW GAMBRO TECHNICAL SERVICES TO INSPECT THIS MACHINE, HOWEVER, THEIR TECHNICAL SERVICES DID INSPECT THE MACHINE AND PROVIDED A VERBAL REPORT OF THEIR INSPECTION. ACCORDING TO ARCH WOOD, DAVITA TECHNICAL SERVICE, THE FOLLOWING COMPONENTS WERE CHECKED AND FOUND TO BE WITHIN THE MFR'S SPEC: ARTERIAL AND VENOUS PRESSURE TRANSDUCERS - SATURATION AND LEAK; CONDUCTIVITY; TEMPERATURE; PUMP OCCLUSION; BYPASS VALVE LEAK; HEAT EXCHANGER LEAK; TOTAL UF ACCURACY AND PH. APPROX 13-15 OTHER DIALYSIS PTS WERE TREATED WITHOUT SYMPTOMS AT THE SAME TIME AS THIS INCIDENT. THEREFORE, THE WATER SYSTEM WAS NOT FURTHER INVESTIGATED. CONCLUSION: THE PT SUSTAINED A BLOOD LOSS AS EVIDENCED BY THE REPORTED DECREASE IN HEMOGLOBIN. HOWEVER, IT CAN NOT BE DETERMINED IF THE CAUSE OF THE DECREASED HEMOGLOBIN IS DUE TO THE RETROPERITONEAL BLEED OR HEMOLYSIS AS ADEQUATE LAB DATA WAS NOT SUPPLIED BY THE FACILITY. THE CAUSE OF DEATH FOR THIS PT IS UNK AS WELL. THE REPORTED ARTERIAL AND VENOUS PRESSURES SUPPORT THE OBSERVATION OF A KINK IN THE ARTERIAL DIALYZER LINE AS FLOW THROUGH THE EXTRACORPOREAL CIRCUIT WOULD HAVE BEEN DECREASED DUE TO THE KINK. IT CAN NOT BE DETERMINED IF A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS PT'S DEATH AS INADEQUATE INFO WAS SUPPLIED IN THIS INVESTIGATION TO DETERMINE HEMOLYSIS OR IF HEMOLYSIS RESULTED IN THIS PT'S DEATH.

    Description of Event or Problem · 1

    GAMBRO RENAL PRODUCTS WAS NOTIFIED OF A CUSTOMER COMPLAINT ON 8/7/2006 VIA MEDWATCH # 262562-06-0001. NOTE: PAR# 56733199 HAS BEEN CANCELED AND REPLACED WITH PAR# 56859699 TO REFLECT THE HEMOLYSIS INCIDENT AGAINST THE SYSTEM AND NOT THE DISPOSABLE SET. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED BY THE CLINIC. INCIDENT: GRP RECEIVED A MEDWATCH ON 8/7/06. PER THE MEDWATCH: JUST PRIOR TO THE CONCLUSION OF HEMODIALYSIS TREATMENT, THE PT EXPERIENCED SEVERE ABDOMINAL PAIN, NAUSEA, AND UNPRODUCTIVE VOMITING. A NURSE OBSERVED THAT THE PT ALSO HAD MIDLINE TENDERNESS AND ABDOMINAL DISTENTION. THE PT WITH THE ASSISTANCE OF HIS DAUGHTER WAS DIRECTED TO OBTAIN MEDICAL TREATMENT AT A HOSP EMERGENCY ROOM FOR POSSIBLE ABDOMINAL BLEEDING. FOLLOWING RINSEBACK OF BLOOD FROM THE EXTRACORPREAL CIRCUIT, A NURSE OBSERVED THE ARTERIAL BLOOD LINE WAS KINKED AT A LOCATION JUST ABOVE THE DIALYZER CONNECTOR. THE PT EXPIRED IN 2006 DURING A DIALYSIS SESSION BEING PROVIDED IN-HOSPITAL. A VERBAL REPORT FOR THE TREATMENT RECORD WAS SUPPLIED BY THE FACILITY. THE PT WAS A MALE WITH A HISTORY OF DIABETES AND PRIOR CARDIAC ISSUES. THE PT'S WEIGHT IS LISTED ON THE MEDWATCH AS 86 KG. THE PT'S DIALYSIS ACCESS IS A FISTULA. THE PRE-DIALYSIS BLOOD PRESSURES WERE: STANDING 144/61 MMHG; SITTING 145/66 MMHG. THE PT DIALYZES FOR 3 1/2 HOURS. THE PT DID NOT BECOME SYMPTOMATIC UNITL THE END OF THE TREATMENT. UPON RETURN OF THE PT'S BLOOD AT THE END OF TREATMENT, THE NURSE NOTED A KINK IN THE ARTERIAL DIALYZER LINE APPROX 1 INCH ABOVE THE ARTERIAL DIALYZER CONNECTOR. CHRISTINE HOLTMEYER REPORTS THAT THE PT'S BLOOD PRESSURE TRENDED UPWARD DURING THE TREATMENT. POST DIALYSIS BLOOD PRESSURES WERE REPORTED AS: STANDING 170/83 MMHG; SITTING 191/92 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM 3 HEMODIALYSIS MACHINE FII GAMBRO HEALTH CARE CENTRYSYSTEM 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death