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

Model Number LIBERTY SELECT CYCLER

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

Patient Problems Dyspnea (1816); Uremia (2188); No Code Available (3191)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

During routine follow up on an unrelated customer experience, the peritoneal dialysis nurse reported that the peritoneal dialysis patient was admitted to the hospital on (b)(6) 2018 for fluid overload.There was no report of a device malfunction.Additional information was solicited.

Manufacturer Narrative

Correction: event date.Additional information: fluid overload, kalemia.Clinical review: there is a temporal relationship between the patient event of shortness of breath, hyperkalemia, hyperglycemia and uremic syndrome with subsequent hospitalization and pd therapy on the liberty select cycler.Although the patient experienced insufficient dialysis and missed treatments, he declined to follow the technical support instructions on how to re-setup after the pressure leak message and in turn did not have manual supplies on hand to drain.It is unknown why the patient did not complete pd therapy for the following two days.There is no documentation to show a causal relationship between the adverse event and the liberty select cycler.Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.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.

Event Description

Additional information was solicited and obtained on 13/jun/2018 through the peritoneal dialysis registered nurse (pdrn) and the discharge summary.It was reported that the patient had been travelling and was experiencing issues with the liberty select cycler (pressure leak message).During that call to technical support for the pressure leak message, the patient did not want to re-setup supplies and stated he would drain manually if needed, however, it was stated by the pdrn that the patient had not brought his supplies to complete a manual exchange on his trip.As a result the patient had insufficient dialysis over a three day period.When the patient returned from travelling he felt unwell and presented to the emergency room (er) on (b)(6) 2018 with uremic syndrome secondary to two days of missed dialysis and shortness of breath.The patient was also diagnosed with hyperkalemia (values unknown) secondary to acidemia (unknown lab values).The hospital course was to continue pd therapy to correct the uremia and hyperkalemia and repeat the patient¿s electrocardiogram (ekg) at the completion of pd therapy.The pd solution was increased to 4.25% delflex in order to remove the excess fluid.A chest x-ray showed mild congestive heart failure with prominent pulmonary vascular congestion.The patient¿s shortness of breath resolved and was comfortable on room air with an o2 sat above 94%.The patient was found to be hyperglycemic (values unknown) and per the patient it was not due to diabetes, but pd therapy.The patient uses a sliding scale to control.The patient was discharged (b)(6) 2018 and disposition is unknown.

• 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
• MDR Report Key: 7605256
• MDR Text Key: 111172580
• Report Number: 2937457-2018-01705
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIODERONE; COREG; HYDRALAZINE; LIBERTY CYCLER SET; NORVASC; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR