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

Catalog Number RTLR180343

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

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Pulmonary Edema (2020); Complete Heart Block (2627)

Event Date 11/25/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, 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 manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

During follow up on an unrelated event, a peritoneal dialysis (pd) patient reported that she had been hospitalized due to a heart attack.During follow up the patient's nurse reported the patient went in to the hospital on (b)(6) 2017 and has been discharged (unknown date).The patient complained of shortness of breath and went to the hospital.The patient was not in treatment nor connected to the cycler at that time.A day after hospitalization on (b)(6) 2017, the patient had a heart attack and was temporarily moved to hemodialysis.The nurse could not comment if heart attack was related to use of pd solution or dialysis.The patient was discharged and has since been recovering.

Manufacturer Narrative

Although a temporal association exists between the liberty select cycler and the reported adverse event(s) of worsening sob, pulmonary edema, nstemi and the need for hospitalization.There is no documentation in the medical record supporting a causal relationship between the liberty select cycler and the adverse events.However, there is significant documentation of coronary artery disease, as well as the following cardiac risk factors: hypertension, hyperlipidemia, diabetes which most likely the caused/contributed to the current adverse events.It is also noted in the x-ray results from (b)(6) 2017 stated that acute coronary syndrome is suspect as the most likely cause of the flash pulmonary edema/heart failure.There is no documentation or allegation against any fresenius product(s) or device(s) malfunctioned or did not perform as expected.

Event Description

During follow up on an unrelated event, a peritoneal dialysis (pd) patient reported that she had been hospitalized due to a heart attack.During follow up the patient's nurse reported the patient went in to the hospital on (b)(6) 2017 and has been discharged (unknown date).The patient complained of shortness of breath and went to the hospital.The patient was not in treatment nor connected to the cycler at that time.A day after hospitalization on (b)(6) 2017, the patient had a heart attack and was temporarily moved to hemodialysis.The nurse could not comment if heart attack was related to use of pd solution or dialysis.The patient was discharged and has since been recovering.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7153223
• MDR Text Key: 96003362
• Report Number: 2937457-2017-01454
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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
• Device Age: MO
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; AMLODIPINE; CHOLECALCIFEROL; CLONIDINE; COLACE; DELFLEX PD SOLUTION; DELFLEX PD SOLUTION; FUROSEMIDE; GENTAMYCIN CREAM (PD CATHETER EXIT SITE); HUMALOG MIX 75/25; HYDRALAZINE; HYDROCHLOROTHIAZIDE; LIBERTY CYCLER SET; LIBERTY CYCLER SET; MIRALAX; RENVELA; SENSIPAR; VITAMIN C; ZOFRAN (AS NEEDED ¿ NAUSEA)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR