MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uremia (2188)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the reported power button issue with the liberty select cycler and the patient¿s hospitalization for uremia and weakness.It was reported the patient did not complete pd treatment with the cycler or manual pd exchanges for 1 week prior to the hospitalization.Patients with esrd require dialysis regularly to mitigate hospitalization from complications related to kidney failure, such as uremia.Therefore, given the reported issue with the power button, the liberty select cycler cannot be ruled out as a contributory factor in the patient¿s hospitalization.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 and diagnosed with uremia.Upon follow up with the pd nurse, it was reported the patient the patient had trouble with the power button on the liberty select cycler while away on vacation and had called to request a replacement.There was no record of a call from the patient in two months prior.As a result of the alleged cycler button difficulties, the patient was unable to complete pd treatments with the cycler and did not perform any continuous ambulatory peritoneal dialysis (capd) manual exchanges for a week.The patient subsequently developed symptom of weakness.On (b)(6) 2019 the patient was admitted to the hospital with uremia.The patient was still hospitalized as of (b)(6) 2019; no discharge summary is available.The nurse stated the patient is receiving pd therapy while hospitalized.The nurse attributed the hospitalization to not completing pd treatment.

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: 9406200
• MDR Text Key: 169020326
• Report Number: 2937457-2019-03520
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR