BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLECTIVE CONCENTRATE- ACID

    MDR report key: 7635502 · Received June 25, 2018

    Report

    Report Number
    2937457-2018-01781
    Event Type
    Death
    Date Received
    June 25, 2018
    Date of Event
    June 4, 2018
    Report Date
    October 22, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(6) MALE ACUTE RENAL PATIENT WITH ACUTE KIDNEY INJURY ARRIVED FOR A SCHEDULED HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S HD DIALYSATE PRESCRIPTION CALLED FOR GRANUFLO DIALYSATE COMPOSITION OF 3.0 K+, 2.5 CA BATH. TREATMENT WAS INITIATED AND AFTER APPROXIMATELY 20 MINUTES AT 12:38 HOURS THE PATIENT WASN¿T FEELING WELL AND THE REGISTERED NURSE (RN) WENT TO GET THE GLUCOMETER. THE PATIENT HAD A PULSE AND STATED HE HAD LOW BLOOD SUGAR THAT MORNING (VALUES UNKNOWN). THE MACHINE ALARMED FOR LOW CONDUCTIVITY. IT WAS AT THAT TIME, THAT IT WAS DISCOVERED THAT THE PATIENT WAS PROGRAMMED FOR 3.0 K+ BATH, BUT IN FACT, A 2.0 K+ BATH WAS BEING UTILIZED. THE PATIENT WAS PLACED ON THE PRESCRIBED 3.0 K+ BATH VIA JUG (DISCONNECTED FROM DIALYSATE CENTRAL FEED FROM WALL). AT 12:40 HOURS THE PATIENT BECAME UNRESPONSIVE, WAS REMOVED FROM THE MACHINE AND THEN A CODE WAS CALLED. THREE RNS WERE AT CHAIRSIDE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AUTOMATED EXTERNAL DEFIBRILLATOR (AED) PADS WERE APPLIED AND THE PATIENT WAS BAGGED UTILIZING AMBU BAG WITH OXYGEN. AT 1242 HOURS CPR CONTINUED, 1L 0.9% NORMAL SALINE (NS) WAS ADMINISTERED THROUGH THE VENOUS PORT OF THE CENTRAL LINE. THE AED INDICATED NO SHOCK ADVISED. AT 12:45 HOURS CPR WAS CONTINUED AND EMERGENCY MEDICAL SERVICES (EMS) ARRIVED. NO SHOCK WAS STILL ADVISED AND NO PULSE WAS NOTED. AT 12:48 HOURS EMS WAS CHAIRSIDE AND BLOOD WAS NOTED FROM THE ORAL CAVITY. THE PATIENT WAS MOVED TO THE FLOOR AND SUCTION WAS APPLIED FROM THE CART. EMS APPLIED THEIR AED BUT NO SHOCK WAS STILL INDICATED AND THE PATIENT WAS ADMINISTERED EPINEPHRINE (VOLUME UNKNOWN). CPR CONTINUED AND A TRANSPORT REPORT WAS GIVEN TO EMS AND SUBSEQUENTLY THE PATIENT WAS TRANSPORTED VIA EMS TO THE HOSPITAL WHERE HE SUBSEQUENTLY EXPIRED. ADDITIONAL RESUSCITATIVE EFFORTS ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PHYSICIAN SUMMARY OF EVENT IN PHYSICIAN SUMMARY OF EVENT: THIS INCIDENT OCCURRED AT FRESENIUS KIDNEY CARE CLINIC FACILITY IN (B)(6) ON (B)(6) 2018 AND CONCERNS AN (B)(6) MALE DIABETIC PATIENT WITH ACUTE KIDNEY INJURY WHO APPROXIMATELY 20 MINUTES FOLLOWING INITIATION OF FIRST SESSION OF IN- CENTER HD, SUSTAINED AN EPISODE OF SUDDEN CARDIAC ARREST THAT SUBSEQUENTLY LED TO A FATAL OUTCOME. RELEVANT ASSOCIATED COMORBIDITIES WAS SIGNIFICANT FOR CARDIOVASCULAR DISEASE WITH ATRIAL FIBRILLATION AND HYPERTENSION. THE USER FACILITY TEAM (CLINICAL, OPERATIONS AND TECHNICAL SERVICES) CARRIED OUT A DETAILED INVESTIGATIONS AND RULED OUT A DIRECT CAUSAL RELATIONSHIP TO HD CONCENTRATE GRANUFLO TO ATTRIBUTE PATIENT DEATH. THE USER FACILITY DID NOT IDENTIFY ANY RELEVANT MACHINE ANOMALIES OR PRODUCT NON- CONFORMITY ISSUES, WHILE THE MACHINE THAT WAS IN USE AT THAT TIME ON THIS PATIENT IS BACK IN SERVICE AT THE FACILITY. CARDIOVASCULAR DISEASE MORBIDITY IS A LEADING CAUSE OF MORTALITY IN HD SETTING, WHERE SUDDEN CARDIAC ARREST IS NOT UNCOMMONLY OBSERVED. FMC- RTG CONSIDERS THAT DEATH MOST LIKELY OCCURRED SECONDARY TO NATURAL COURSE OF END STAGE ACUTE KIDNEY DISEASE COMPLICATIONS ASSOCIATED WITH PRE-EXISTING CARDIOVASCULAR DISEASE COMORBIDITIES.

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: THERE IS A TEMPORAL RELATIONSHIP BETWEEN THE HEMODIALYSIS (HD) THERAPY ON THE FRESENIUS 2008T MACHINE AND THE PATIENT NOT FEELING WELL, CARDIOPULMONARY ARREST, AND SUBSEQUENT DEATH. THERE IS NO DOCUMENTATION IN THE FILE TO SHOW THAT THE 2008T MACHINE CAUSED THE PATIENT ADVERSE EVENT. THE USER PROGRAMMED THE MACHINE FOR 3.0 K+ DIALYSATE CONCENTRATION (THE PATIENT¿S PRESCRIPTION), HOWEVER, ACTUALLY CONNECTED TO A 2.0 K+ DIALYSATE CONCENTRATION WHICH RESULTED IN THE MACHINE OPERATING AS EXPECTED AND ALARMING FOR LOW CONDUCTIVITY. IT IS LIKELY THAT THE USE OF THE INCORRECT POTASSIUM CONCENTRATION CAUSED OR CONTRIBUTED TO THE PATIENT CODING AND SUBSEQUENTLY EXPIRING. CARDIOVASCULAR DISEASE IS A LEADING CAUSE OF DEATH IN DIALYSIS PATIENTS WITH A LARGE PROPORTION ATTRIBUTED TO CARDIAC ARREST. THIS PATIENT DID HAVE UNDERLYING CARDIAC ISSUES INCLUDING ATRIAL FIBRILLATION WHICH CAN BE AFFECTED IF THE PATIENT IS HYPOKALEMIC. ELECTROLYTE DISORDERS ARE ONE OF THE MAIN HD-RELATED FACTORS THAT CAN CAUSE QT INTERVAL ALTERATIONS AND CARDIAC ARRHYTHMIAS. IT IS UNKNOWN IF THE PATIENT¿S ACUTE KIDNEY INJURY OR ANY CONCOMITANT MEDICATIONS COULD HAVE BEEN A FACTOR IN THE CARDIAC ARREST. THE MOTHERBOARD SHORTING OUT DUE TO BLEACH BEING FOUND ON THE BOARD, RESULTED IN POWER FAILURE AFTER THIS EVENT OCCURRED AND THE PATIENT WAS DISCONNECTED FROM THE MACHINE. BASED ON THE AVAILABLE INFORMATION, THE MACHINE DID NOT MALFUNCTION DURING THE HD TREATMENT FOR THIS PATIENT. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE COMPLAINT SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER OF PRODUCT INVOLVED IS UNKNOWN. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE FACILITY FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THE REVIEW REVEALED SIX LOT NUMBERS. A RECORDS REVIEW WAS PERFORMED ON THE LOT NUMBERS. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT REVEAL ANY ISSUE DURING THE MANUFACTURING PROCESS AND ALL INSPECTION AND RELEASE CRITERIA WERE MET. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DHR REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. BASED ON THE RESULTS OF THE SEARCH, AND SINCE THERE ARE NO PRODUCT MALFUNCTIONS REPORTED WITHIN THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE A CAUSE RELATED TO THE PRODUCT MANUFACTURING PROCESS FOR THE COMPLAINT ALLEGATIONS. THE COMPLAINT CANNOT BE TRACED TO THE DEVICE AS THERE IS NO PRODUCT MALFUNCTION AND/OR OUT OF SPECIFICATION REPORTED; THEREFORE, THE PROBABLE CAUSE THAT LED TO THE USE OF THE INCORRECT POTASSIUM CONCENTRATION IS UNKNOWN, AND THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT CODED AND SUBSEQUENTLY EXPIRED DURING HD THERAPY ON (B)(6) 2018. THE BIOMEDICAL TECHNICIAN (BIOMED) AT THE USER FACILITY REPORTED THAT THE PATIENT WAS SUPPOSED TO RUN A GRANUFLO 3K, 2.5CA BATH, HOWEVER WAS RUNNING A BATH THAT WAS 2K, 2.5CA (PRODUCT NUMBERS NOT PROVIDED). WHEN THE MISTAKE WAS DISCOVERED, THE WAND WAS PULLED FROM THE WALL BOX ACID CONNECTOR AND PUT IT INTO JUGS WITH THE CORRECT BATH. THE BIOMED REPORTED THAT THE BICARBONATE ORDER WAS FOR 35, AND BICARBONATE CHEMICAL ANALYSIS CAME BACK AT 35 WHEN TESTED, AND THAT THE CONDUCTIVITY ANALYSIS WAS 13.6 MS/CM, AND THE PH WAS 7.2. THE BIOMED REPORTED THAT THE PATIENT WAS ON THE WRONG ACID BATH AND STATED THAT THEY WERE NOT FEELING WELL. THE PATIENT HAD BEEN CONNECTED FOR APPROXIMATELY TWENTY MINUTES WHILE THE MACHINE HAD A LOW CONDUCTIVITY ALARM. THE BIOMED REPORTED THAT THEY TOOK LEL (LIMULUS AMOEBOCYTE LYSATE), COUNTY COUNT, PH TEST, BICARB CHEMICAL ANALYSIS, AND FUNCTION TESTS ON THE MACHINE WHILE IT WAS ON THE TREATMENT FLOOR. UPON BRINING THE MACHINE BACK FOR FURTHER TESTING, THE MACHINE WOULD NOT POWER ON. THE BIOMED REPORTED THAT THE STAFF STATED THE MACHINE SHUT ITSELF OFF, BUT HAD NO AUDIBLE ALARM. AT THAT POINT IN TIME, A REQUEST WAS MADE FOR A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) TO COME ON SITE TO EVALUATE THE MACHINE. THE FRESENIUS RES TECHNICIAN CAME ONSITE AND FOUND THE MOTHERBOARD HAD A LARGE SPOT OF BLEACH RESIDUE THAT CAUSE IT TO SHORT OUT. THE RES TECHNICIAN REPLACED THE MOTHERBOARD TO RESOLVE THE POWERING OFF ISSUE. AFTER MACHINE REPAIR, THE RES TECHNICIAN PERFORMED FUNCTIONAL CHECKS TO ENSURE THAT THE MACHINE WAS OPERATING PROPERLY AND NO MACHINE ERRORS WERE FOUND. UPON FOLLOW UP WITH THE CLINIC, THE HD NURSE CONFIRMED THAT THE PATIENT CODED AND SUBSEQUENTLY EXPIRED. THE NURSE STATED THAT A FEW MINUTES INTO THE PATIENT¿S HD TREATMENT, THE PATIENT BECAME UNRESPONSIVE AND A CODE WAS CALLED. THE PATIENT¿S TREATMENT WAS DISCONTINUED AND CARDIOPULMONARY RESUSCITATION (CPR) INITIATED UTILIZING AN AMBU BAG WITH OXYGEN AND SUCTION APPLIED. THE PATIENT WAS SENT TO THE HOSPITAL UNRESPONSIVE AND EXPIRED AT THE HOSPITAL BELIEVED THE PATIENT HAD A VAGAL RESPONSE AS THEY WERE NEW TO HD THERAPY AND HAD MULTIPLE COMORBIDITIES. THE PATIENT WAS REPORTED TO HAVE HYPOPARATHYROIDISM, DIABETES MELLITUS (TYPE 2), HYPERTENSION, ATRIAL FIBRILLATION, AND WAS AN ACUTE RENAL PATIENT DUE TO AN ACUTE KIDNEY INJURY (AKI). ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476820 COLLECTIVE CONCENTRATE- ACID DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R FRESENIUS 2008T MACHINE