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 Chest Pain (1776); Inflammation (1932)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a possible temporal relationship between peritoneal dialysis (pd) therapy utilizing the liberty select cycler and the patient¿s chest pain with hospitalization and subsequent diagnosis of pericarditis; however, it is unknown if the patient was in treatment at the time of the event.The patient¿s peritoneal dialysis registered nurse (pdrn) stated there is no documentation in the hospital record indicating the pericarditis was caused by any liberty select cycler malfunction or pd deficiency as reported by the patient.The pdrn reviewed the patient¿s treatment data which did not indicate ineffective treatment.One treatment, post-hospitalization, was noted to have a negative uf.The patient continues treatment without issue on the same liberty select cycler.Based on the available information and no documentation of a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s chest pain with diagnosis of pericarditis.

Event Description

A peritoneal dialysis (pd) patient reported that they were hospitalized, and it was related to their heart.The patient stated that their doctor stated that they had inflammation due to toxins not leaving their body.The patient also stated that they have had recurring drain problems since receiving the cycler several months earlier.Additional information was obtained through the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was hospitalized on (b)(6) 2020 with chest pain.The patient was subsequently diagnosed with pericarditis.A review of the patient¿s hospital record did not indicate the cause of the pericarditis being documented as the liberty select cycler or inefficient peritoneal dialysis as reported by the patient.The patient was discharged from the hospital on (b)(6) 2020.Details pertaining to hospital course were not provided.The patient was seen in the pd clinic on (b)(6) 2020.The patient did not report any issues with the liberty select cycler or any draining issues to the pdrn.The patient was found to have no problems during the pd visit.The patient continues to complete pd therapy utilizing the same liberty select cycler without issue.

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-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.

• 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
• MDR Report Key: 10891264
• MDR Text Key: 217996460
• Report Number: 2937457-2020-02110
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR