MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Cardiac Arrest (1762); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Malaise (2359); Loss of consciousness (2418)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine, and the adverse events of malaise, syncope, loss of consciousness and non-cardiac chest pain, which required hospitalization.The patient¿s discharge summary states the patient likely experienced an episode of intradialytic hypotension (syncopal episode) versus a cardiac event.Intradialytic hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments.Very often, the cause of hypotension is multifactorial.While there is no allegation or objective evidence indicating the 2008t hemodialysis machine caused the events, the 2008t hemodialysis machine cannot be excluded from having a possible contributory role.Given the 2008t hemodialysis machine required recalibration during post event functional compliance testing, there is insufficient evidence to definitively conclude what preempted the syncopal episode and loss of consciousness.Additionally, the patient¿s diarrhea was unknown to the outpatient dialysis center and could have impacted the patient¿s hemodynamic stability during hd therapy.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A fresenius res (regional equipment specialist) technician was called onsite by a user facility to perform a device evaluation of a 2008t machine.Upon follow up, the res stated that during functional checks, they found that the uf pump was over by 0.1 ml.The res confirmed that there was patient involvement.The res stated that the patient had coded on the machine.A review of the treatment record from 4/nov/2019 confirmed the patient arrived via wheelchair in stable condition for her regularly scheduled hd treatment.The patient¿s pre-treatment vitals were; weight = (b)(6) kg ((b)(6) kg above edw), blood pressure (bp) = 136/70, heart rate (hr) = 64, respirations (rr) = 16, temperature (t) = 97.8.The treatment began at 11:27 am and was uneventful until 12:31 pm when the patient¿s treatment was stopped to allow the patient to use the restroom (of note: the discharge summary indicates they felt ill while ambulating, and never made it to the restroom).The patient returned and hd therapy was resumed (time not provided) at 12:45 pm, stated they feel well (e.G.Moaning, eyes closed) and became unresponsive (suspected cardiac arrest).The patient was placed in the trendelenburg position, oxygen was applied at 10 liters via mask, normal saline (ns) was administered (1000 ml), cardiopulmonary resuscitation (cpr) was initiated (4-5 rounds compressions/breaths) and emergency medical services (ems) was contacted at 12:47 pm.An automated external defibrillator (aed) was applied to the patient at 12:50 pm and advised no shock.The patient regained consciousness and was talking by 13:10 pm when ems arrived.The patient¿s bp was 86/47 with a hr of 30 upon discharge to the hospital.Upon arrival to the emergency room, the patient was alert and oriented x3 and complaining of chest pain from cpr (treated with dilaudid).An electrocardiogram (ekg) and computed tomography (ct) scan were performed and showed no acute changes.A chest x-ray was also obtained and ruled out any rib fractures.The patient informed the attending physician they had been experiencing diarrhea for approximately two weeks.The patient was taken to the intensive care unit (icu) and placed on telemetry overnight with plans to perform a transthoracic echocardiogram and right upper quadrant ultrasound on (b)(6) 2019.Overnight the patient¿s troponin remained free from elevation, and all testing performed on (b)(6) 2019 failed to reveal any significant acute changes or cardiac involvement.Follow-up physician notes stated the suspected ¿cardiac arrest¿ was more likely due to hypotension, rather than a true arrhythmic arrest.Given the patient¿s ekg was negative for ischemia, no elevation of troponin, no neurological acute deficits, there is low suspicion for a primary cardiac or arrhythmic event.Hd therapy continued while the patient was hospitalized, and the patient was discharged with a 30-day cardiac event monitor.The patient returned to the outpatient dialysis center on (b)(6) 2019 in stable condition and resumed hd therapy without difficulty.A functional compliance testing (fct) was performed by the nursing staff immediately following the events.All aspects of the fct were within manufacturer specifications, however the uf control was unable to be assessed (rationale not provided).The 2008t hemodialysis machine was sequestered following the events, and on (b)(6) 2019 a fresenius regional equipment specialist (res) arrived to perform additional testing.During validation testing, the res noted the uf volume strokes were out-of-range.The validation result was 24.2 ml, which is 0.1 ml over the allowable range of 23.9 ml ¿ 24.1 ml (successfully recalibrated).Also, during testing the loading pressure valve was replaced due to noise, and the ¿green¿ shunt door wire harness was damaged and required replacement.The remainder of the validation testing fell within manufacturer specifications, and the 2008t hemodialysis machine was returned to service.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A fresenius field service technician (fst) performed the requested evaluation after which the machine passed self-testing 3 times.Function checks were performed, and the uf volume stroke checked at 24.2ml out of 24 strokes (+0.1ml out of range).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.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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
• MDR Report Key: 9394997
• MDR Text Key: 168774636
• Report Number: 2937457-2019-03495
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 68