MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fall (1848); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Hypernatremia (2242); Respiratory Failure (2484); Confusion/ Disorientation (2553)

Event Date 06/01/2020

Event Type  Death  

Manufacturer Narrative

It was noted the patient also required 2 cardiac stents to the left anterior descending (lad) artery with respect to the myocardial infarction.Per the charge nurse, the patient¿s nephrologist attributed the myocardial infarction to pre-existing cardiac comorbid conditions.Additionally, an mri of the brain was also performed (date unknown) which showed that the patient suffered a significantly large embolic stroke in multiple areas of the brain.The patient continued hemodialysis during hospitalization, and it was noted the hypernatremia was corrected.The patient did not awaken with removal of sedation and spontaneous awakening trials (sat) from mechanical ventilation.Furthermore, a head ct scan (on (b)(6) 2020) could not rule ongoing brain insult.The patient¿s prognosis was medically deemed poor and the patient¿s family withdrew life support.The patient was extubated and placed on comfort measures only and subsequently expired on (b)(6) 2020.The charge nurse reported the 2008t machine was pulled from service and it was confirmed through documentation on the post event functional testing of the dialysis machine performed on (b)(6) 2020 that all functional testing of the 2008t machine passed.Additionally, according to documentation on the form, the functional tests verified the conductivity and ph of the dialysate used at the time of the event were within parameters.The nurse reported the bicarbonate was not suspected to have caused the patient¿s hypernatremia as it was distributed to all patients in the clinic and no additional patients had any symptoms or harm.Furthermore, the charge nurse stated the acid bath for not suspected to have caused the patient¿s hypernatremia.The machine was returned to service post functional testing without any further issues or events.

Event Description

It was reported via voluntary medwatch that on (b)(6) 2020 a hemodialysis (hd) patient was receiving hd treatment via the 2008t machine.The patient¿s recorded pre-treatment vital signs included blood pressure (bp) 130/75 sitting, 116/63 standing; pule 78, respiratory rate (rr) 16, and temperature 97.1.Subsequently, the patient requested to interrupt treatment to use the bathroom (bp pressure 130/88, pulse 88).The patient subsequently fell in the bathroom and was alert but confused/not answering questions appropriately post fall.Patient vital signs recorded included bp 171/86 (elevated), pulse 90, rr 19, temperature 97.1 and blood sugar 134.The patient was sent to the hospital via emergency medical services for further evaluation and it was recorded the patient was found to have an elevated sodium level of 167.During hospitalization, the patient had cardiac stenting and subsequently expired on (b)(6) 2020.Additional follow-up was conducted with the user facility¿s charge nurse.Per the nurse, all pre-treatment safety checks of the machine were completed and passed on the day of the event.Per the nurse, there were no reported machined alarms or anything out of the ordinary with respect to the patient¿s treatment.The hd treatment sheets were provided and reviewed and according to documentation on the patient¿s treatment sheet, the machine passed all tests, machine conductivity was within range, and ph documented at 7.0.The patient¿s pre-treatment weight recorded (b)(6) kg with a target weight calculated at 2.3 kg (2300 ml ultrafiltration) as dry weight is (b)(6) kg.It was noted the patient arrived in stable condition without any complaints of chest pain or shortness of breath.A review of all pre-treatment documentation revealed no unexpected findings.At 6:25 am, treatment was initiated without any problems or complaints.Subsequently, between 6:32am and 7:31 am the patient had transient elevation in blood pressure (160/86), however, the patient denied any complaints.A review of previous hemodialysis treatment information on (b)(6) 2020 revealed the patient has a history of elevated blood pressure during treatment.At 7:56 am the patient was taken of dialysis to go to the bathroom with complaint of headache.The patient was given 200 cc of normal saline and blood pressure recorded 130/88, pulse 98.Per the charge nurse, the patient walked assisted by a staff person to the bathroom without any difficulty.While in the bathroom, the patient sustained a fall.It was reported by the charge nurse that the patient did not sustain any physical injuries.Per the treatment sheet, the patient hit their head and was confused/disoriented when evaluated by staff.The patient¿s bp upon returning from the bathroom was recorded at 171/90 (elevated), pulse 86 and blood sugar was 134.The patient did not resume hd treatment and was sent to the hospital via ambulance at 8:45 am for further medical evaluation.Per the charge nurse the patient was stable upon discharge from the dialysis clinic but remained disoriented.A review of the patient¿s hospital record for (b)(6) 2020 was performed.Documentation included that the patient¿s vitals in the emergency department (ed) included the bp was 155/68, pulse 89, oxygen saturation 98% on room air, rr 20 and temperature 36.1.Patient labs were significant for elevated troponins (28.52; 31.68), sodium 162, carbon dioxide 18.5, chloride 139, brain natriuretic peptide 530.7, blood ph 7.25 and blood glucose 179.The patient was intubated with mechanical ventilation (sedation using fentanyl and propofol) and admitted to the intensive care unit (icu) with an admitting diagnosis that included acute respiratory failure, non-st elevation myocardial infarction (nstemi), hypernatremia (cause unknown) with pre-existing end-stage renal disease (esrd) and diabetes mellitus (dm).

Manufacturer Narrative

Additional information: event correction: event plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformance's, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

Correction: during hospitalization, the patient had cardiac stenting and subsequently expired on 06/05/2020.Clinical investigation: a temporal relationship exists between hd treatment via the fresenius 2008 t machine, fresenius naturalyte acid bath and fresenius bicarbonate solution and the patient¿s complaint of headache with evidence of hypertension and subsequent fall and altered mental status while the patient paused hd treatment to go to the bathroom.Currently, there is no objective evidence contained in the file that indicates a malfunction or product issue with the products caused this event.At this time, the exact cause of the event cannot be determined.Dialysis is a life-sustaining therapy for patients with esrd.However, it is well documented that patients with esrd on dialysis can have imbalance with electrolytes and experience hypertension due to disease process of kidney failure.Additionally, the patient was hospitalized, and it was discovered the patient suffered a myocardial infarction.The patient¿s reported symptoms during the hd treatment may have been a manifestation of the patient¿s underlying cardiac condition.The myocardial infarction is unlikely to be related to use of any fresenius product due to the patient requiring 2 stent placements in a major artery in the heart.Moreover, it was reported the patient¿s nephrologist attributed the myocardial infarction to the patient¿s pre-existing comorbid conditions.The patient¿s myocardial infarction is likely to be associated with the patient¿s acute respiratory failure and large embolic stroke with ongoing insult to the brain and placement on mechanical ventilation for life support.The patient¿s medical prognosis was deemed poor due to the extent of injury and the patient¿s family subsequently withdrew life support and the patient subsequently expired.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10337785
• MDR Text Key: 200778189
• Report Number: 2937457-2020-01348
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO BICARBONATE; FRESENIUS NATRALYTE BICARBONATE; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO BICARBONATE; FRESENIUS NATRALYTE BICARBONATE
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 53