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 Problem No Information (3190)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: attempts to obtain additional information were unsuccessful.The reason for the patient¿s hospitalization is unknown; however, there is no information suggesting that it was related to the use of the liberty select cycler or any fresenius product(s).Additionally, there is no allegation of a device malfunction or deficiency reported for the event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support to request assistance with the liberty select cycler.The patient is currently hospitalized and utilizing the hospital¿s cycler.The fresenius technical support representative advised the patient to follow-up with their doctor regarding the treatment-related questions.Requests for additional information were made, however to date a response has not been received.The reason for the patient¿s hospitalization is unknown.It is confirmed that the caller is a fresenius patient with a home cycler.However, there is no information suggesting that the patient's hospitalization was related to the use of the liberty select cycler or any fresenius product(s).Additionally, there is no allegation of a device malfunction or deficiency reported for the event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other 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: 11109180
• MDR Text Key: 224829364
• Report Number: 2937457-2021-00005
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/08/2021
• 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