BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4832812 · Received June 9, 2015

    Report

    Report Number
    1225714-2015-03830
    Event Type
    Death
    Date Received
    June 9, 2015
    Date of Event
    April 26, 2013
    Report Date
    June 2, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SALES SEARCH DID NOT IDENTIFY PRODUCTS SHIPPED TO THE FACILITY DURING REPORTED EVENT BASED ON THE 8 PAGES OF MEDICAL RECORDS IT APPEARS THAT THE PATIENT PRESENTED WITH CHEST PAIN AND A NEW ONSET OF BUNDLE BRANCH BLOCK. DURING HOSPITALIZATION, THE ONLY MEDICAL MANAGEMENT WAS HEMODIALYSIS FOR HER CHRONIC KIDNEY DISEASE AND ASPIRIN, PLAVIX AND ATORVASTATIN FOR HER PERIPHERAL VASCULAR DISEASE. PATIENT EXPERIENCED A NON-RESPONSIVE EPISODE ON (B)(6) 2013 REQUIRING NO INTERVENTION PATIENT EXPERIENCED A PULSELESS EVENT ON (B)(6) 2013 REQUIRING 3 ROUNDS OF EPINEPHRINE, CARDIOPULMONARY RESUSCITATION AND INTUBATION. PATIENT WAS PLACED IN THE ICU CODE STATUS WAS CHANGED TO A DO NOT RESUSCITATE AND PATIENT PLACED ON SODIUM MORPHINE DRIP PATIENT EXPIRED ON (B)(6) 2013 AT 12:14AM ACCORDING TO THE DEATH CERTIFICATION THE CAUSE OF DEATH WAS ANOXIC BRAIN DAMAGE DUE TO CORONARY ARTERY DISEASE AND END STAGE RENAL DISEASE AUTOPSY WAS NOT PERFORMED. ALTHOUGH A REQUEST WAS MADE FOR COMPLETE AND RELEVANT MEDICAL RECORDS INCLUDING DIALYSIS TREATMENT SHEETS, PROGRESS NOTES LABORATORY AND DIAGNOSTIC TESTS, THE MEDICAL RECORDS DID NOT INCLUDE SUCH ITEMS. BASELINE SERUM LAB VALVES INCLUDING A BICARBONATE BLOOD/LAB LEVEL WERE NOT INCLUDED. THERE WAS NO INDICATION THE PATIENT RECEIVED DIALYSIS ON (B)(6) 2013, (B)(6) PROGRESS NOTES. BASED ON REVIEW, THIS PATIENT HAD CHRONIC CORONARY ARTERY DISEASE THAT REQUIRED MEDICAL INTERVENTION BUT, THE PATIENT WAS NOT A CANDIDATE FOR THESE REQUIRED INTERVENTIONS. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES THERE WAS A CAUSAL RELATIONSHIP BETWEEN GRANUFLO OR NATURALYTE AND THE PATIENT'S PULSELESS EVENT OR DEATH. THERE IS NO DOCUMENTATION IN THE MEDICAL THAT REVEALS THE PATIENT WAS USING GRANUFLO OR NATURALYTE AT THE TIME OF THE PATIENT'S NON-RESPONSIVE EPISODE, PULSELESS EPISODE OR DEATH. THE PATIENT HAD A SIGNIFICANT MEDICAL HISTORY. THE CAUSE OF DEATH AS NOTED ON THE DEATH CERTIFICATE IS TOXIC BRAIN DAMAGE FROM DISEASE STATES CORONARY ARTERY AND END-STAGE RENAL FAILURE. IT APPEARS THE PATIENT'S COMPLEX, EXTENSIVE MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE EVENT. (RELATED FILE 1225714-2015-03829).

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADD'L INFO.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPIRED FROM THE FOLLOWING INJURY: END STAGE RENAL DISEASE, CORONARY ARTERY DISEASE AND TOXIC BRAIN DAMAGE, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED TO THE PT FOR DIALYSIS TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THE FOLLOWING DETAILS FOR THE EVENT. THE PATIENT PRESENTED TO THE EMERGENCY ROOM, ONE DAY PRIOR TO HER BIRTHDAY COMPLAINING OF LEFT-SIDED CHEST PAIN THAT STARTED WHEN THE PATIENT HAD WOKE UP THAT MORNING. THE LEVEL OF PAIN WAS A 7 ON A SCALE OF 1-10. THE PATIENT DESCRIBED THE PAIN AS ON AND OFF, RADIATING TO THE LEFT ARM AND BACK, LASTING FOR 1-2 MINUTES WITH NO NAUSEA OR VOMITING. PATIENT DENIED PALPITATION OR LIGHTHEADEDNESS. THERE WAS NO ORTHOPNEA PRESENT. PATIENT WAS ADMINISTERED ASPIRIN AND A NITRO PATCH, PAIN IMPROVED AND WAS ADMITTED. THREE DAYS LATER THE PATIENT DE-SATURATED TO HIGH 80'S ON 6 LITERS OXYGEN PER MINUTE BIPAP WAS ORDERED BUT, THE NURSE WAS NOT READY TO USE THE BIPAP OVERNIGHT. TWO DAYS THEREAFTER, THE PATIENT HAD A RAPID RESPONSE CALLED. THE PATIENT WAS NON-RESPONSIVE WITH EYES ROLLED BACK AND MOUTH TWITCHED FOR ABOUT 5 MINUTES. CONSCIOUSNESS WAS REGAINED WITHOUT INTERVENTIONS. PATIENT RECEIVED BEDSIDE DIALYSIS AND 2 LITERS WERE REMOVED. PATIENT WAS PLACED ON OVERNIGHT BIPAP AND EVENING WAS UNEVENTFUL. THE NEXT DAY, PATIENT WAS SWITCHED TO OXYGEN VIA NASAL CANNULA. AT MID-MORNING, A RAPID RESPONSE WAS CALLED. THERE WAS NO DETECTABLE PULSE, A CODE BLUE WAS CALLED AND CPR INITIATED. PATIENT HAD A NON-SHOCKABLE RHYTHM 3 ROUNDS OF EPINEPHRINE WERE ADMINISTERED PATIENT WAS INTUBATED. EVENTUALLY A PULSE WAS DETECTED. PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT PATIENT'S CODE STATUS WAS CHANGED TO DO NOT RESUSCITATE LIFE SUPPORT WAS WITHDRAWN. THE NEXT MORNING PATIENT DESATURATED, BECAME BRADYCARDIC AND REACHED ASYSTOLE. THERE WAS NO EVIDENCE OF ANY RESPIRATORY EFFORT, HEART SOUND, PUPILLARY RESPONSE OR PULSE SEEN. PATIENT EXPIRED AT 12 :14AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372724 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| L