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 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Clinical statement: based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient contact requested assistance with bypassing drain 0 of 4.The patient drained 8 ml of 1240 ml due to being empty.Technical support informed the patient contact on how to bypass to fill 1 of 4.The patient began filling at a good rate.Upon follow up, the patient contact confirmed the reported event.The patient contact stated that the patient was hospitalized on (b)(6) 2020 and admitted slow draining and fibrin then discharged on (b)(6) 2020.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using the cycler on (b)(6) 2020.The patient contact confirmed that the patient is recovering and continuing with peritoneal dialysis with manual exchange until seen at the clinic for further direction.Upon follow up with the patient's pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2020 following drain complications during continuous cyclic pd (ccpd) therapy on the liberty select cycler at home.It was reported the patient had experienced multiple alarms on the cycler involving drain complications prior to this hospitalization.There was no report of the patient experiencing a serious injury or adverse event that could potentially cause or contribute to this event.The patient was able to undergo hemodialysis (hd) through an existing fistula on a hospital provided hd machine (unknown brand and model) during this admission.The patient had an uneventful hospital course and was discharged on (b)(6) 2020.The patient is scheduled for a pd catheter (not a fresenius product) evaluation as it is suspected the pd catheter may be the source of the drain complications during ccpd therapy.It was stated this event was not due to a specific deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on in-center basis post-discharge and plans to continue ccpd therapy on the same liberty select cycler upon resolution of her drain complications.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

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.

Manufacturer Narrative

Correction: a4 missing in initial report.

• 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: 11071851
• MDR Text Key: 223601953
• Report Number: 2937457-2020-02327
• 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,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• 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: 01/14/2021
• 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
• Patient Age: 87 YR
• Patient Weight: 63