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 Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Uremia (2188); Hypervolemia (2664)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Clinical statement: 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 was hospitalized for high blood pressure and abdominal pain.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) confirmed that the patient was hospitalized with symptoms of abdominal pain and high blood pressure.The patient was also admitted with a diagnosis of fluid volume overload and uremia.The fluid volume overload and uremia were unrelated to use of the liberty select cycler or any other fresenius product(s).The patient was non-compliant with pd therapy by skipping treatments resulting in the adverse event.The patient was discharged on (b)(6) 2020.The patient had a baxter connection on the pd catheter (not a fresenius product) when discharged and completed manual exchanges until seen at the pd clinic on (b)(6) 2020 to have the connection changed.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.

• 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: 10635311
• MDR Text Key: 210003247
• Report Number: 2937457-2020-01794
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• 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: 10/27/2020
• 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: 54 YR