BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 5357015 · Received January 6, 2016

    Report

    Report Number
    2937457-2016-00029
    Event Type
    Death
    Date Received
    January 6, 2016
    Date of Event
    October 28, 2014
    Report Date
    January 6, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE PLANT INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ALL PRODUCTS ARE RELEASED ACCORDING TO SPECIFICATIONS AND MEET REQUIREMENTS BEFORE ENTRY INTO THE FIELD. A DEVICE EVALUATION, INCLUDING A DEVICE HISTORY REVIEW COULDN'T BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN AND THE DEVICE WASN'T RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND HAVE BEEN REVIEWED BY POST MARKET CLINICAL STAFF. ON (B)(6) 2014, THE PATIENT STARTED HEMODIALYSIS AT 06:54. VITAL SIGNS WERE AS FOLLOWS: BLOOD PRESSURE 192/107, TEMPERATURE 96.4, PULSE 67, WEIGHT 73.4. THE PATIENT'S HEPARIN WAS HELD DUE TO CATHETER SURGERY SCHEDULED LATER THAT DAY. MEDICAL RECORDS REVEAL ON (B)(6) 2014, THE PATIENT HAD A REVISION OF THE PERITONEAL DIALYSIS CATHETER AND LAPAROSCOPIC LYSIS OF ADHESIONS UNDER GENERAL ENDOTRACHEAL ANESTHESIA. THE PATIENT AWOKE FROM ANESTHESIA, EXTUBATED WITHOUT INCIDENT, AND TAKEN TO THE RECOVERY ROOM IN "PERFECTLY GOOD" CONDITION. MEDICAL RECORDS DO NOT MENTION THE PATIENT WAS DISCHARGED HOME. ACCORDING TO THE END STAGE RENAL DISEASE DEATH NOTIFICATION, THE PATIENT EXPIRED ON (B)(6) 2014 FROM CARDIAC ARREST, CAUSE UNKNOWN. MEDICAL RECORDS DO NOT CONTAIN A HISTORY AND PHYSICAL, ANY PROGRESS NOTED FROM THE HOSPITAL OR DIALYSIS CLINIC, MEDICATION LISTS, SURGICAL DISCHARGE INSTRUCTIONS, DIAGNOSES, OR PHYSICIAN ORDERS FOR REVIEW. MEDICAL RECORDS REVEAL THE PATIENT WAS STABLE AFTER THE SURGICAL PROCEDURE. MEDICAL RECORDS DO NOT CONTAIN A DEATH CERTIFICATE OR AUTOPSY REPORT FOR REVIEW. MEDICAL RECORDS DO NOT MENTION A HISTORY OF CARDIAC ISSUES. HOWEVER, THE DAY BEFORE THE PATIENT'S DEATH, THE PATIENT HAD AN ELEVATED POTASSIUM LEVEL THAT COULD CONTRIBUTE TO ARRHYTHMIAS. THE PATIENT'S BICARBONATE LEVEL 3 DAYS PRIOR TO DEATH WAS NORMAL. MEDICAL RECORDS CONTAIN VERY LITTLE INFORMATION TO DETERMINE THE CAUSE OF THE PATIENT'S CARDIAC ARREST. HOWEVER, AN ELEVATED POTASSIUM LEVEL AND THE PATIENT'S POST-OPERATIVE STATUS INVOLVING ANESTHESIA CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTORS TO THE PATIENT'S CARDIAC ARREST. MEDICAL RECORDS DO NOT MENTION ANY INTERVENTIONS OR ANY HOSPITALIZATION FOR THE PATIENT'S CARDIAC ARREST. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES A CAUSAL RELATIONSHIP BETWEEN THE 2008T HEMODIALYSIS MACHINE AND THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    A CORRESPONDENCE LETTER WAS RECEIVED WHICH INDICATED A PT WAS DECEASED. A FOLLOW UP CALL WAS MADE WITH THE CLINIC ASSOCIATED WITH PT'S TREATMENT IN ORDER TO GATHER ADDITIONAL DETAILS ABOUT THE EVENT SURROUNDING THE PT'S DEATH. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PT HAD SWITCHED FROM PERITONEAL DIALYSIS TO IN-CENTER HEMODIALYSIS, AND THAT THE PT HAD CHANGED DIALYSIS CENTERS. A FOLLOW UP CALL WAS MADE WITH THE PT'S FINAL HEMODIALYSIS CLINIC AND THE NURSE THERE INDICATED THAT THE PT HAD PASSED AWAY AT HOME FROM A HEART ATTACK ON (B)(6) 2014. NO FURTHER INFO COULD BE OBTAINED IN REGARDS TO THE SEQUENCE OF EVENTS LEADING UP TO THE PT'S DEATH. NO REPORTED ALLEGATIONS WERE MADE AGAINST THE MACHINE. THE PT'S ESRD DEATH NOTICE LISTS CARDIAC ARREST WITH UNK CAUSE AS THE CAUSE OF DEATH. FURTHER MEDICAL RECORDS HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    THE PATIENT COMPLETED A HEMODIALYSIS TREATMENT ON (B)(6) 2014. LATER THAT DAY, THE PATIENT HAD A REVISION OF THE PERITONEAL DIALYSIS CATHETER AND LAPAROSCOPIC LYSIS OF ADHESIONS UNDER GENERAL ENDOTRACHEAL ANESTHESIA DUE TO THE PATIENT NOT BEING ABLE TO DRAIN FROM THE PERITONEAL DIALYSIS CATHETER FOR THE PREVIOUS TWO WEEKS. THE PATIENT AWOKE FROM ANESTHESIA, EXTUBATED WITHOUT INCIDENT AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. PATIENT REMAINED STABLE. PATIENT EXPIRED AT HOME ON (B)(6) 2014, DUE TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7677 2008T HEMODIALYSIS SYS., WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death