MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Device Issue (2379)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pulmonary Edema (2020); Respiratory Distress (2045); Vomiting (2144); Hypervolemia (2664)

Event Date 02/18/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

A peritoneal dialysis patient's nurse reported the patient was hospitalized for fluid overload.The nurse reported the cycler had alarmed for unknown alarms and the patient was not able to complete treatment using the cycler.The cycler was replaced.During follow up the nurse reported the patient was initially hospitalized (b)(6) 2018 for hypervolemia due to inadequate peritoneal dialysis.The patient had reported the cycler had alarmed and she was performing manual treatments.However, the patient could not provide evidence of performing manual treatments and the nurse was not sure they were completed.The nurse reported the patient has a history of non-compliance with treatment.The patient was discharged from the hospital (b)(6) 2018 after the hypervolemia was resolved.The patient's event wa last reported to be resolved.

Manufacturer Narrative

A possible temporal relationship exists between the pt.Allegedly experiencing unknown alarms (dates unknown) during ccpd treatment with the liberty cycler and subsequent acute onset of respiratory distress and chest pain which resulted in hospitalization for hypervolemia, pulmonary edema and hypertensive urgency.It was alleged the unknown alarms on the liberty cycler prevented the pt.From completing ccpd treatments prior to hospitalization (dates unknown).Moreover, it appears the pt.Was not performing manual pd treatments (in lieu of cycler assisted therapy) which may have been a factor in the pt¿s hypervolemia and pulmonary edema event.Furthermore, the pt¿s medical history of hypertension, episodic shortness of breath (associated with her anemia of chronic kidney disease) and pneumonia with persistent cough may also be associated with the pt¿s respiratory distress and chest pain.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Additional information was solicited and received.On (b)(6) 2018, the patient (pt) presented with acute onset of respiratory distress.The pt.Had associated symptoms of chest pain/pressure and occasional nausea and vomiting elicited by her cough.The pt¿s physical exam in the er positive for significant hypertension (blood pressure (bp) 229/155, tachycardia (pulse (p) 111), tachypnea (respiratory rate (rr) 24) with evidence of crackles in bilateral lung bases and 1+pitting edema in bilateral lower extremities (ble) which went to knee level.A chest x-ray performed (on (b)(6) 2018) showed evidence of small layering pleural effusions and diffuse interstitial lung opacities with enlarged cardiac silhouette suggesting heart failure and pulmonary edema.The pt.Was treated for hypertension.However, her bp did not improve (recorded as 210/128).The pt.Was subsequently ordered for a total of 30 milligrams(mg) of hydralazine.The pt.Also required nitroglycerin for intermittent chest pain which resulted in bp drop to 130/64 (pt¿s bp recorded 192/118 prior to nitroglycerin).Additionally, it was recorded the pt.Would be given antibiotics for suspected pneumonia (drug, dose, route unknown).The pt.Was stabilized in the er awaiting transfer to another facility that could accept the pt.On (b)(6) 2018, the pt.Was admitted inpatient on telemetry due to acute pulmonary edema/ fluid volume overload secondary to inadequate pd at home, with hypertensive urgency and pneumonia (suspected) of both lungs due to infectious organism (unknown organism).The pt.Was continued on aggressive cycled pd therapy while hospitalized which improved the pt¿s fluid status.(ccpd treatment details and products are unknown).Further details surrounding the pt¿s hospitalization course are unknown.The pt.Was discharged home on (b)(6) 2018 continuing pd therapy with doxycycline by mouth for 1 week.Per the pd nurse, the pt.Was being evaluated for the ability for the pt.To care for herself after hospital discharge.

Manufacturer Narrative

The complaint symptom motor pump a was confirmed.The complaint symptom pl patient line is blocked warning was not confirmed.Encountered (invalid sensor reading 5-volt).A visual inspection of the returned cycler exterior showed no signs of physical damage.When attempting to down load the stored treatment data, an (invalid sensor reading 5-volt) occurred.During testing, multiple (invalid sensor reading 5-volt) occurred.A simulated treatment was performed and completed.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.An accelerated stress test identified a grinding pump motor a.While the cycler was turned on and left idle, after approximately ten minutes a warning occurred.The 5 volt display was fluctuating.A check of the -> diagnostics ¿ a to-d - voltages screen showed that the 5 volt display was drifting, changing from 5.05 volts to 5.00 volts.Due to the voltage failure, the power supply module was replaced.After replacing the module, the cycler unit was left on for approximately 24 hours.No further support warnings occurred.A subsequent (as-received) simulated treatment was performed and completed without failures.During that time, no further power related alarms occurred.There were no fluid leaks in the test cassette during the treatment tests.In the internal, visual inspection of the unit of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.There were was a brown hp2 filter within the cycler unit.The cause of the encountered discoloration could not be determined.Mushroom head check passed.Tested positive for glucose.A dhr was performed.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7346873
• MDR Text Key: 102706448
• Report Number: 2937457-2018-00801
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORVASTATIN; CALCIUM ACETATE; CARVEDILOL; CHOLECALCIFEROL; FERROUS SULFATE; LIBERTY CYCLER SET; OXYCODONE-ACETAMINOPHEN; PD FLUID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 86