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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10337785
MDR Text Key200778189
Report Number2937457-2020-01348
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2017
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: 07/29/2020 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO BICARBONATE; FRESENIUS NATRALYTE BICARBONATE
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