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); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Pain (1994); Loss of consciousness (2418); Lethargy (2560)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing the 2008t and the patient¿s serious adverse events.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.However, the patient was recently hospitalized for several cardiac comorbid conditions.Per the cm, the serious adverse events did not occur due to a fresenius device(s) and/or product(s) deficiency or malfunction.This is further confirmed by the functional testing completed on the machine.The patient¿s death was directly attributed to a withdrawal of care per the patient¿s dnr order.Intradialytic hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments.Very often, the cause is multifactorial.Additionally, the esrd population has significantly higher mortality and fewer expected years of life when compared to the general population.Of these patients, cardiovascular disease (or sudden cardiac death) accounts for the most deaths.The 2008t can be disassociated from the events based on this information.There is no allegation or objective evidence indicating a fresenius device/product deficiency or malfunction caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device/product failed to meet user expectations or manufacturer specifications.Plant investigation: no parts were returned to the manufacturer.A records review was performed.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.Objective evidence was not found indicating a product problem, thus the complaint is unconfirmed.

Event Description

A user facility biomedical technician (biomed) contacted fresenius technical services and requested an onsite evaluation of a machine after a patient "coded" during hemodialysis (hd) treatment.A fresenius field service technician (fst) was dispatched to the user facility to evaluate the machine.Additional information was obtained during follow-up with the clinic manager (cm).The patient presented to the outpatient hd clinic on (b)(6) 2023 for their first outpatient hd treatment.Upon arrival the patient complained of being tired (lethargic), weak and experiencing pain in their buttocks.The patient¿s vitals were: blood pressure (b/p) = 68/37 (rechecked 106/60), heart rate (hr) = 56, respiration rate (rr) = 18, temperature = 96.2, and despite an estimated dry weight of 55.5 kgs, the patient¿s weight prior to treatment was 47.1 kgs.The patient¿s treatment was initiated, and the ultrafiltration (uf) goal was set at 500 ml due to the patient¿s reported weakness and weight discrepancy.The patient¿s b/p was 84/48 following initiation, and the blood flow rate (bfr) was set at 300 ml/min.The patient received a 100 ml normal saline (ns) bolus as ordered for b/p support but refused to be placed in the trendelenburg position.The nephrologist was notified and ordered all uf to be discontinued.Additionally, the patient was given a bolus of 150 ml of ns, the 2008t hd system¿s temperature lowered to 35.0 (36.5 standard), and oral midodrine 10 mg (stat) as well as 5 mg (mid-treatment) was ordered/administered.Within 15 minutes of initiating treatment, the patient's b/p dropped to 76/43 (hr = 58).Within 20 minutes, the patient¿s hd catheter (not a fresenius product) was alarming (arterial pressure) and despite several interventions (specifics not provided) the hd catheter¿s function could not be restored.The nephrologist was notified, the patient¿s blood was reinfused, and emergency medical services (ems) was contacted to transport the patient to the hospital due to hypotension and a malfunctioning hd catheter.An evaluation of the 2008t hd system¿s conductivity, ph and temperature following the termination of treatment were all found to be within normal limits.Following the termination of treatment, the patient was reportedly alert, oriented, and communicating effectively, despite having continued pain in their buttocks and lower back (chronic).At 9:25 am while awaiting ems, the patient became unresponsive (agonal breathing, negative sternal rub) and their eyes rolled back into their head (b/p = 145/106 and hr = 94).At 9:26 am, the patient¿s hr and breathing could no longer be detected, and cardiopulmonary resuscitative (cpr) measures were initiated (chest compressions, ambu bagged, 3-15 liters of oxygen).911 was contacted, an automated external defibrillator (aed) was applied to the patient, and cpr was continued.The aed indicated no shock was advised, and care of the patient transitioned to ems at 9:40 am.Ems established an airway via an endotracheal tube, and the patient was enroute to the hospital by 9:50 am.Per the hospital¿s electronic record, the patient had cardiac activity, however the hospital discovered the patient had a do not resuscitate (dnr) order from a previous hospitalization, at which point all lifesaving measures were discontinued.The patient subsequently expired and was transported to the funeral home.Per the nephrologist the cause of death was a withdrawal of care.Per the cm, the serious adverse events were unrelated to any fresenius device(s), drug(s) and/or product(s).Following the discontinuation of treatment, the 2008t hd system was removed from service.On (b)(6) 2023, a biomedical technician performed a post-event evaluation of the 2008t hd system, and the device passed all functional compliance and uf testing.Following the successful evaluation, the device was returned to service on (b)(6) 2023.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17272974
• MDR Text Key: 318578844
• Report Number: 0002937457-2023-00972
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/06/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 56 KG