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

Catalog Number RTLR180343

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

Patient Problems Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); Hypervolemia (2664)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.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-conformance's, 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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical review: there is a temporal relationship between pd therapy with the liberty select cycler and the patient¿s hospitalization for congestive heart failure (characterized by chest pain, dyspnea and leg edema).However, there is no objective evidence that indicates a liberty select cycler product deficiency or malfunction caused the patient¿s adverse event.The exact etiology for the patient¿s chf cannot be determined at this time.However, it was reported the patient had ongoing fluid volume overload prior to hospitalization which is a known risk factor for chf in esrd patients.It is unknown what exactly caused the patient¿s fluid volume overload.Fluid management in esrd patients on pd therapy can be influenced by many variables (such as pd prescription, diet, patient compliance) and fluid volume overload is not uncommon occurrence in patients with renal failure.

Event Description

It was reported that a patient on continuous cycling peritoneal dialysis (ccpd) was hospitalized due to congestive heart failure (chf).The patient¿s peritoneal dialysis registered nurse (pdrn) was not able to identify the exact cause of the patient¿s congestive heart failure nor was etiology for chf specifically identified in the medical records.Per the pdrn, the patient was fluid volume overloaded (prior to hospitalization) with symptoms of swelling, shortness of breath (dyspnea), increased weight, increased blood pressure (bp).As a result, the patient trained for a last fill of extrarenal solution (not a fresenius product) to help with fluid overload and was being monitored via the outpatient pd clinic.However, subsequently, the patient presented to the emergency room (er) with worsening leg edema, dyspnea and chest pain and the patient was admitted to the cardiac floor.Serial cardiac enzymes were obtained which showed an elevated creatinine phosphokinase (cpk) of 212, creatinine kinase (ck)-mb 8.1 and troponin 158.Cardiac catheterization and echocardiogram were performed which did not yield any significant cardiac abnormality, per documentation in the medical records.The patient was treated for chf with intravenous (iv) lasix and subsequently switched to torsemide 100 mg daily.The patient¿s pd prescription was adjusted (details unknown) and continued pd therapy while hospitalized and the patient¿s symptoms improved.Two days later, the patient had a recorded weight of 83.3 kg (which is above the patient¿s recorded dry weight of 77 kg) and was deemed stable for discharge home.The patient continued pd therapy on the liberty select cycler.

• Brand Name: LIBERTY SELECT CYCLER ASSY(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: 8079680
• MDR Text Key: 127541274
• Report Number: 2937457-2018-03411
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 77