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); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s hospitalization for chest pain, dyspnea and hypertension.The etiology of the events is not identified during the admission; therefore, causality cannot be firmly established.However, the pdrn reported the events were unrelated to the utilization of any fresenius device(s) or product(s).Additionally, the patient has a history of hypertension, and the discharge summary indicates she needs a post-discharge liver ultrasound and a nuclear stress test for further evaluation.Based on the limited information available, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the events.Despite the pdrn¿s disassociation of all fresenius product(s) and device(s); the lack of treatment records, a more detailed discharge summary and no manufacturer evaluation of the suspect device (not returned to manufacturer), means there is insufficient evidence to exclude the liberty select cycler from the events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

During a follow up call with a peritoneal dialysis (pd) patient it was reported that the patient on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was hospitalized on (b)(6) 2020 for cardiac issues, shortness of breath (dyspnea), and high blood pressure (hypertension).It is unknown if the onset of the symptoms occurred during pd treatment.Upon further follow up with the patient¿s peritoneal dialysis registered nurse (pdrn), a discharge summary was received which revealed that the patient presented to the emergency room (er) with chest pain, dyspnea, and hypertensive urgency.The document does not indicate what, if any, medical intervention was performed during the hospitalization.The patient underwent radiological testing (e.G.Electrocardiogram, echocardiogram, chest x-ray); however, it does not appear the cause of the events was discovered.The patient was discharged on 6/mar/2020 in stable condition and given follow-up instructions which included the patient following-up with cardiology and her primary care provider.Per the pdrn, the events are unrelated to the patient¿s utilization of the liberty select cycler or any fresenius product(s) or device(s).The current disposition of the patient, as well as any results from the post-discharge follow-up testing was not provided.

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-conformance's, 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: 9845677
• MDR Text Key: 183877025
• Report Number: 2937457-2020-00510
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 50