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

Catalog Number RTLR180111

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Uremia (2188)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship between the patient not being able to continue pd therapy, resulting in the hospitalization for hypotension and elevated blood urea nitrogen (bun) level, and the liberty cycler alarm issue exists.However, per pd nurse the patient has been non-compliant in completing pd therapy which would also cause the event of hypotension and elevated bun levels.Additionally, it is not known when the patient completed their last treatment on the liberty cycler, or if the patient has any co-morbidities that would contribute to the hospitalization.This patient is known to be non-compliant in regards to pd therapy.A potential causal relationship can be concluded for the increase in the patient¿s bun levels if the patient was not being able to complete dialysis treatment due to the recurring alarm on the liberty cycler.The causality for the hypotension is not found based on the limited information provided.Adherence to dialysis treatments is of paramount importance as missed treatments have been shown to result in an increased risk of mortality and hospitalization.Plant investigation: an investigation of the device was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.A visual inspection of the returned cycler exterior showed no sign of physical damage.Simulated treatment was performed and completed without any unexpected alarms or problems occurring.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.There were no discrepancies encountered in the internal inspection of the cycler.The system air leak test, valve actuation test, voltage check, temperature test and mushroom head check passed.The reported problem of the repeat ¿invalid sensor reading¿ alarm was not confirmed.There were no reported device malfunctions that would have caused the reported event.

Event Description

A peritoneal dialysis (pd) patient called regarding reoccurring invalid sensor reading alarms and stated they were hospitalized.During follow up the pd nurse stated the patient was hospitalized (b)(6) 2017 due to hypotension and elevated blood urea nitrogen (bun) levels.Additionally it was reported the patient was unable to complete their treatment due to receiving multiple alarms.Further follow up revealed the cause of patient¿s hospitalization was the patient being non-compliant with their treatment.The patient has continued pd treatment throughout the hospital stay, however it is unknown if fresenius products were used or not.The pd nurse stated the patient has recovered from the event and was performing treatment without further issues.

Manufacturer Narrative

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 batch 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: 6914183
• MDR Text Key: 88166708
• Report Number: 2937457-2017-00990
• 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: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• 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: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2015
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 70