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

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Device Issue (2379)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Pulmonary Edema (2020); Electrolyte Imbalance (2196); Respiratory Failure (2484); Hypervolemia (2664)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted upon the completion of the plant's investigation.There is no documentation in the medical records or complaint file supporting a possible causal association between the liberty cycler and the events of respiratory distress/failure and cardiopulmonary arrest.The patient has a well-established history of non-compliance with pd therapy, medication compliance, as well as not keeping clinic visit appointments, and appointments with pdrn for home visits.Therefore, a certain association exist between the patient¿s complex medical history, comorbidities, non-compliance with treatment and the event of respiratory failure and cardiopulmonary arrest.

Event Description

A peritoneal dialysis (pd) patient¿s contact reported that the patient felt like she was continuing to receive a fill during drain cycles and that the patient was currently in the hospital for fluid in her lungs.No alarms or warnings were reported.Treatment data was reviewed and determined the patient had not been completing treatment on the cycler and was bypassing the last prescribed fill volume.Due to the contact¿s concern the cycler was replaced.Via follow up with the patient¿s pd nurse and medical records it was reported that the pd patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) presented on (b)(6) 2017 to the emergency room (er) via emergency medical system with worsening shortness of breath and severe back pain (chronic, and not relieved by tramadol) since the night of (b)(6) 2017.The patient¿s daughter reported that the patient¿s breathing on the evening of (b)(6) 2017 became increasingly labored, until the morning of (b)(6) 2017 when reportedly the patient was not able to breath.Upon arrival to er the patient cardiorespiratory arrested; cardiopulmonary resuscitation (cpr) was initiated, a left external jugular intravenous access was obtained and the patient was intubated, placed on ventilator support and was sedated.At some point (time unknown) in the er the patient was hypertensive with a blood pressure (bp) of 221/147.The patient received nitroglycerin ointment which caused the patient to become significantly hypotensive (systolic bp as low as 73) and thus the patient required vasopressor (dopamine) support, systolic bp rebounded to 100.During the cardiopulmonary arrest the patient electrocardiogram captured the cardiac rhythm of rapid atrial fibrillation with a rapid ventricular response which spontaneously converted into a normal sinus rhythm requiring no intervention.The patient was admitted to the intensive care unit with severe respiratory failure and pulmonary edema for care, cardiac monitoring, and aggressive pulmonary toileting.Additionally, the patient was in acute heart failure as demonstrated with a bnp of 1826, additionally the patient¿s albumin level was 2.8.The patient was severely hyponatremic with a sodium level of 120.The plan was to receive regular dialysis (utilizing pd if possible) to remove excess fluid, improve sodium level, and improve the patient¿s respiratory status.The patient was discharged on (b)(6) 2017 to home.Post discharge the patient was performing manual pd exchange without further issues.A home visit was made on (b)(6) 2017 by pdrn, an attempt was made during visit to have patient resume ccpd.However, the nurse reported that the patient is anxious, when getting on cycler and getting into bed at night.

Manufacturer Narrative

An exterior visual inspection showed no signs of physical damage.A simulated treatment was performed and completed without failures.The system air leak and valve actuation tests passed.The voltage check also passed.The temperature calibration at ambient temperature test passed.The load cell value and verification was within tolerance, and the patient sensor calibration check passed.There were no discrepancies encountered in the internal inspection of the cycler.Additionally, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6322616
• MDR Text Key: 67154847
• Report Number: 2937457-2017-00092
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

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: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/14/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2009
• 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: LIBERTY CYCLER CASSETTE; PD FLUID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 95