MAUDE Adverse Event Report: HEMODIALYSIS (HD) CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problem Pressure Problem (3012)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Lethargy (2560); Respiratory Arrest (4461)

Event Date 06/15/2023

Event Type  Death  

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 19/jun/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 22/jun/2023.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEMODIALYSIS (HD) CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• MDR Report Key: 17298059
• MDR Text Key: 318800705
• Report Number: MW5119246
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: 2008T HD SYSTEM; AMBU BAG (OXYGEN ADMINISTRATION); AUTOMATED EXTERNAL DEFIBRILLATOR (AED); ENDOTRACHEAL TUBE; MIDODRINE (ORAL); NORMAL SALINE
• Patient Outcome(s): Death
• Patient Weight: 47 KG