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); Dyspnea (1816)

Event Date 12/28/2020

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the adverse events of dyspnea, cardiac arrest, and death.The patients death certificate listed the primary cause of death as cardiac arrest, secondary to cad, diabetes mellitus, and esrd.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 30-fold higher than the general population.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.However, given the events occurred during treatment and the patients blood was returned; the 2008t hemodialysis system cannot be disassociated from 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 this patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) was having difficulty breathing (dyspnea) during hd therapy.It was reported the patients blood was returned, at which point they lost consciousness and cardiopulmonary resuscitative (cpr) measures were instituted.Treatment records indicate the patient arrived for their regularly scheduled hd treatment, alert but disoriented (baseline not provided), with complaints of dyspnea.The patients pre-treatment vital signs included blood pressure (b/p) = 102/50, pulse = 100 bpm, temperature = 97.2, respiration rate = 18, pre-treatment weight =(b)(6).The pre-treatment machine checks were completed/passed, and the patients hd treatment began at 12:27.At 12:31, the patients registered nurse (rn) was assisting the patient care technician (pct) with repositioning the patient, when it was noted the patient was experiencing increased dyspnea and was only minimally responding to verbal stimuli.The patient was already receiving supplemental oxygen (volume unknown) for dyspnea, and at 12:35 the patient lost consciousness while the rn was returning their blood (volume not provided).Automated external defibrillator (aed) pads were placed on the patient (no shock advised), and the patient was transferred to the floor.9-1-1 was contacted and cardiopulmonary resuscitative (cpr) measures were initiated at 12:37.Between 12:39 and 12:43 the patient received 1800 ml of normal saline, as cpr continued.The patients b/p ranged from 128/62 (pulse 174 bpm) to 155/73 (pulse 107 bpm), and the aed continued to advise no shock.The paramedics arrived at 12:45 and assumed control of the code.The patient was given two intravenous push (ivp) doses of epinephrine with no response, at which time it was confirmed the patient had a do not resuscitate (dnr) order in place; therefore, all life saving measures were discontinued.The patient was pronounced dead at 12:57, total treatment time was 24 minutes, with 1.74 liters of blood having been processed.The death certificate states the patients primary cause of death was cardiac arrest, secondary to coronary artery disease (cad), diabetes mellitus, in addition to esrd.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: 11252602
• MDR Text Key: 229401478
• Report Number: 2937457-2021-00150
• 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

• Date FDA Received: 01/29/2021
• 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
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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: 82 YR
• Patient Weight: 52