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 Cardiac Arrest (1762); Death (1802)

Event Date 10/17/2020

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the adverse events of venous needle infiltration, cardiac arrest, and death.Per the patients home therapy cm, the primary cause of death was cardiac arrest.Per the cm, the serious adverse events were unrelated to any fresenius device(s) and/or product(s).The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Additionally, adults with esrd have mortality rates up to (b)(4) higher than the general population.Based on the totality of the information available, the 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the events.At this time there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the serious adverse events.Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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-conformances, 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

It was reported to fresenius that the patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) required a second venous needle placement due to an infiltration.While placing the second needle, it was noted the patient was pulseless.The patients blood pressure cuff was adjusted, however there was no change in the findings and cardiopulmonary measures (cpr) were initiated (blood returned).Treatment records indicate the patient arrived for their regularly scheduled hd treatment.The patients pre-treatment vital signs included a blood pressure (b/p)  110/52, pulse = 80 bpm, temperature = 97.4, respiration rate = 18, pre-treatment weight = (b)(6) kgs.The pre-treatment machine checks were completed/passed, and the patients hd treatment began at 13:05.At 14:55, a venous pressure alarm sounded, and it was noted an infiltration occurred at the patients venous needle site.The patients blood was recirculated while the second venous needle was placed (below infiltration due to swelling), and the patients treatment was restarted at 15:02.At 15:03 the 2008t hemodialysis system b/p alarm sounded, and while attempting to adjust the b/p cuff, the patient lost consciousness.Cpr was immediately initiated, and the hd treatment was terminated.Additional details surrounding these events was requested (e.G., was 9-1-1 called, what fluid/medication was provided during code, was an automated external defibrillator applied), however no additional information was provided.The patients total treatment time was 1 hour and 58 minutes, with 1.74 liters of blood having been processed.Per the patients clinical manager (cm) for the outpatient home dialysis clinic, the patients primary cause of death was cardiac arrest.During follow-up, the clinical manager (cm) for the outpatient home dialysis clinic stated there is no indication or allegation the fresenius 2008t hemodialysis system caused or contributed to the patients death.The cm stated the machine was sequestered following the events, and functional compliance testing was performed by an internal bio-medical technician (bmt).According to the cm, the machine passed all ultrafiltration and functional compliance testing following the events and was returned to service.The machine records were requested; however, they were not made available for review.

• 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
• 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 Key: 11254787
• MDR Text Key: 229528256
• Report Number: 2937457-2021-00157
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 113