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

Model Number 180343

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

Patient Problems Dyspnea (1816); Hypervolemia (2664)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient report of incomplete treatment resulting in hospitalization for fluid volume overload.However, the patient did not report any issues with the liberty select cycler to fresenius technical support prior to the blank screen reported after admission to the hospital.Additionally, the patient did not specify any issue when reporting incomplete treatments due to cycler issues to the pdrn prior to the hospitalization.The pdrn cannot confirm the cause of the patient¿s fluid volume overload or reason for incomplete treatments for three days.Per the documentation in the technical support call, the patient had an alternate form of treatment to utilize.Based on the limited information available, it cannot be concluded if the liberty select cycler caused or contributed to the patient¿s hospitalization for fluid volume overload.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-conformances, 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.

Event Description

It was initially reported a peritoneal dialysis (pd) patient did not complete the last two consecutive treatments as they were in the hospital for the past couple of days.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient presented to the emergency room (er) on (b)(6) 2021 with complaints of shortness of breath.The patient was admitted to the hospital with a diagnosis of fluid volume overload (fvo).The pdrn stated the patient reported having incomplete pd treatments for 3 days prior to the hospitalization due to the liberty select cycler not working properly.The patient did not specify what the issue was when reporting this information to the pdrn.The pdrn could not confirm if the blank screen issue was what prevented the patient from having complete treatments prior to hospitalization.The pdrn could not confirm the cause of the fvo.It could not be confirmed if the liberty select cycler caused or contributed to the patient¿s fvo.The patient was discharged to home on (b)(6) 2021.The patient is continuing to complete pd therapy without issue.There was no further information related to the patient¿s fvo event.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11980533
• MDR Text Key: 255675947
• Report Number: 2937457-2021-01226
• 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: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2021

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 Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/23/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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: 61 YR