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Catalog Number 190628
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/01/2018
Event Type  Death  
Manufacturer Narrative
Plant investigation: a regional equipment specialist performed the device evaluation on the machine and found no errors in its operation. The machine passed functional testing. A records review was performed on the serial number. An investigation of the device manufacturing records was conducted. There were no non-conformances or any associated rework identified during the manufacturing process which could be related to the event. The device history record review confirmed the results of the in-progress and final quality control testing met all requirements. Clinical investigation: there is nothing that indicates a 2008k2 machine malfunction caused or contributed to the patient becoming short of breath and unresponsive, with cardiac arrest that led to a fatal outcome. The primary cause of death was cardiac arrest (cause unknown), and a secondary cause was associated with the comorbid condition of chronic obstructive pulmonary disease for which the patient was oxygen dependent. It cannot be determined what led to the patient¿s cardiac arrest due to multi-factorial potential causes. The patient had a significant drop in blood pressure from 215/135 (considerably hypertensive) to 95/49 after 45 minutes of hemodialysis (unknown cause). Hypotension is a considerable risk factor for cardiac arrest in hd patients. The machine encountered an air detected alarm when the patient¿s shortness of breath developed but the blood pump paused as expected (reduces risk for infusion of air). It is unknown if in fact air was "visibility" present in the hd circuit and/or hd catheter related to the patient¿s adverse event. The patient¿s complaints of allergies, sneezing, and a documented allergy to latex cannot be discounted as a possible confounding factor as a severe allergic reaction could have also been a precipitating factor in the patient¿s cardiac arrest. Also, the patient was a long-standing hd patient due to esrd which is a significant risk factor for cardiac related mortality.
Event Description
A user facility reported a patient who "coded" during their (b)(6) 2018 treatment on a fresenius 2008k2 hemodialysis machine. The patient's treatment had been paused to inspect the machine, bloodlines and catheter due to an air detect alarm (no air was found). The patient subsequently became unresponsive. The patient was admitted to the intensive care unit and expired later on (b)(6) 2018. The cause of death was reportedly cardiac arrest. The fresenius 2008k2 machine was later inspected by a fresenius regional equipment specialist (res), who confirmed the machine passed functional testing without issue.
Manufacturer Narrative
Additional clinical investigation information.
Event Description
Additional clinical investigation information: this investigation is in response to a report on (b)(6) 2018 of a patient death on (b)(6) 2018 during a hemodialysis (hd) treatment via 2008k2 machine. Follow-up information revealed this (b)(6) female patient had a past medical history significant for end stage renal disease (esrd) on long-standing hd, severe chronic obstructive pulmonary disease (copd); reportedly oxygen dependent and a documented latex allergy. Hd treatment sheet for (b)(6) 2018 was reviewed and revealed the following: the 2008k2 machine passed all alarm testing during set up and machine conductivity recorded was 14. 2, and machine temperature 35. 4 celsius. The pre-dialysis weight recorded (b)(6), which was (4kg) 4000ml over the recorded dry weight of (b)(6). The patient was alert with no complaints of shortness of breath, nausea, vomiting or diarrhea. It was recorded the patient had complaint of (unknown) allergies and sneezing. It is unknown if the patient received any medication for allergies prior to start of hd treatment. The patient¿s hd prescription included optiflux f 180 nr dialyzer, 2 potassium(k)/3 calcium (ca) dialysate bath with bicarbonate setting 40, blood flow rate of 300ml/min and dialysate flow 600ml/min. The patient¿s pre-dialysis potassium, calcium and bicarbonate level is unknown. The patient¿s recorded ultrafiltration (uf) goal was 4. 3 kg (4300ml) per patient and the uf rate recorded was 1500 ml/ hour which did not exceed the patient¿s 1200ml/hour max fluid removal order. The patient received a 3000 ml bolus of heparin (an anticoagulant). The hd treatment began at 6:13 am via a tunneled right internal jugular hd catheter. The blood pressure recorded at treatment start was 218/135 which was significantly hypertensive and outside of the patient¿s recorded baseline for the prior 4 hd treatments (bp range 128-152/56-88 from (b)(6)). Subsequently, at 6:30 am (approximately 17 minutes after hd initiation) the bp dropped to 163/98. Hd continued. At 7 am (approximately 45 minutes after hd initiation), the patient had another significant drop in bp to 95/49. The total fluid removed to this point in the hd treatment was recorded 951ml. It is unknown if the patient had symptoms of hypotension or if the patient received any normal saline. Subsequently at 7:25 am, it was recorded the 2008k2 machine encountered an air detect alarm. The blood pump on the machine paused (expected) and while the nurse was checking the machine, tubing and hd catheter the patient began to complain of shortness of breath (sob). It is unknown if there was any visible air observed in the circuit or hd catheter. The patient¿s oxygen was increased (unknown amount) and the nurse disconnected the hd tubing from the catheter and began infusing normal saline directly through the hd catheter to replace fluids. A recorded total of 1300 ml of saline was infused to replace a net uf of 1250 ml. The patient sat up and then the nurse observed the patient¿s lips were cyanotic (blue) and they subsequently became unresponsive. It was recorded the patient did not become pulseless and had a recorded pulse of 145 and bp 178/156 in right leg. The code team in the hospital was summoned and at 7:47 am the patient was transferred to the emergency room. It was reported the patient was brought to the intensive care unit and subsequently expired. Resuscitation effort details are unknown. The cause of death was reportedly acute hypoxic failure. Documentation in the esrd death notification form lists cardiac arrest; cause unknown as the primary cause of death and a secondary cause of copd. After the death event, a regional equipment specialist performed testing on the 2008k2 (on (b)(6) 2018) in response to a service request for the machine to be further evaluated to rule out if a machine malfunction could have caused the death. The service confirmation concluded the machine had no errors in operation and passed functional testing.
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Manufacturer (Section D)
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
MDR Report Key7909927
MDR Text Key121741170
Report Number2937457-2018-02871
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190628
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/26/2018 Patient Sequence Number: 1