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 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: additional information was requested, however, to date a response has not been received.There was no allegation of a liberty select cycler malfunction or deficiency reported for the hospitalization or transport to the unspecified lab.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 hospital nurse reported to fresenius technical support that a peritoneal dialysis (pd) patient was in fill 1 of treatment on the liberty select cycler when the patient required transport to the emergency lab.The patient was dwelling with 2,000ml of fluid.Attempts to obtain additional information were unsuccessful.The reason for the patient¿s hospitalization is unknown.It is also unknown why the patient was transported to an emergency lab or what the indication for use of an emergency lab is.It is also unknown whether the patient utilizes fresenius products to complete pd therapy.There was no allegation of a liberty select cycler malfunction or deficiency reported for the hospitalization or transport to the unspecified lab.The nurse was attempting to continue the patient¿s pd therapy on the liberty select cycler, indicating that the patient¿s issue was not pd-related and that the nurse was not trained in the use of the cycler and required assistance from the peritoneal dialysis registered nurse (pdrn).

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: 11059812
• MDR Text Key: 225782079
• Report Number: 2937457-2020-02308
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

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: Health Professional
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/24/2020; 01/13/2021
• Supplement Dates FDA Received: 01/04/2021; 01/25/2021
• 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