MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

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

Patient Problems Abdominal Pain (1685); Atrial Fibrillation (1729); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Constipation (3274)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is no documentation to show a causal relationship between the liberty cycler and the hospitalization for a-fib w/rapid ventricular response, moderate pericardial effusion, hypotension, bilateral shoulder pain, chest pain, abdominal pain and constipation.There is no allegation against any fresenius products in relation to the adverse events.The patient¿s symptoms of bilateral shoulder pain, hypotension and chest pain are consistent with a-fib w/rapid ventricular response and pericardial effusion.The patient has an extensive cardiac history, much of which are probable contributory factors in the development of the bilateral shoulder/chest pain, hypotension, a-fib w/rapid ventricular response and the pericardial effusion.The patient has a history of abdominal pain and there is a probable association between the common gastrointestinal symptoms of abdominal pain, colonic fecal retention, and renal failure as well as renal replacement therapy.Plant investigation: the cycler was returned to the manufacturer for evaluation.A visual inspection of the exterior showed no signs of physical damage.An internal inspection did not show any dried fluid inside the cassette area but there was dried fluid within the recess of the bottom cover by the pump.The cause of the dried fluid was not determined.The device was subjected to a simulated treatment test which was completed without any failures or leaks.The glucose, mushroom head, heater, temperature, and heater calibration tests passed.The voltage check failed at 5 volt but was able to be adjusted using the voltage adjustment potentiometer and then the voltage check passed.A review of the device history records was conducted by the manufacturer.There were no issues found which could be associated with the event.The investigation into the cause of the reported incident was not able to be confirmed.An evaluation of the returned device could not identify any associated malfunctions.

Event Description

A peritoneal dialysis (pd) patient reported that the cycler was giving invalid sensor readings while in treatment on (b)(6) 2017.A review of the cycler alarm history found multiple invalid sensor readings back to (b)(6) 2017.The patient was able to complete treatment by manual therapy with no adverse events and no medical intervention.The patient received a replacement cycler.It was reported that the patient was recently hospitalized from (b)(6) 2017.The admission diagnoses included atrial fibrillation (a-fib) with rapid ventricular response, moderate pericardial effusion (pe), bilateral shoulder/chest pain, hypotension, abdominal pain, and constipation.The patient has a known history of a-fib and was recently hospitalized for a similar event.During the previous admission, the patient was successfully cardioverted and discharged home on coumadin and amiodarone.During the admission on (b)(6) 2017, the recommendation was to cardiovert the patient as before in the er.Cardioversion and the patient converted to a sinus rhythm for a short period of time, then reverted back to a-fib.Subsequently, the patient was given intravenous (iv) amiodarone with good effect.Additionally, the patient¿s coumadin was discontinued as the level was sub-therapeutic and the amiodarone and aspirin were continued.From the er, the patient was transferred to the intensive care unit (icu) for evaluation and treatment of the hypotension.The patient was started on iv vasopressors for blood pressure support.The patient underwent a diagnostic echocardiogram on (b)(6) 2017 and a ct pulmonary angiogram to evaluate the cause of the bilateral shoulder pain and chest pain.A moderate pe was noted, 2.0 cm in diameter.Subsequently, serial echocardiograms were performed on (b)(6) 2017 to monitor the status of the pe.These follow-up echocardiograms showed a decrease in size of the pe from 2.0 cm to 1.4 cm, as well as a small improvement in the ejection fraction (ef).As a result, the patient was able to wean off the vasopressors and her blood pressure (b/p) had been stable at the time of discharge on (b)(6) 2017.A computerized topography (ct) of the abdomen was performed to evaluate the complaints of abdominal pain.The patient has a known history of abdominal pain.The ct showed a moderate amount of stool burden which was treated with miralax, colace, and lactulose with good result.The pd nurse reported that the hospitalization was unrelated to dialysis.The pd nurse confirmed that the patient did not have a heart attack or stroke during pd therapy.The patient received pd therapy while hospitalized and there is no evidence of a prescription change.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• 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: 7057904
• MDR Text Key: 92875625
• Report Number: 2937457-2017-01237
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2017

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: 11/02/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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 SET; PERITONEAL DIALYSIS (PD) FLUID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR