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 No Information (3190)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: it is unknown if a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler and the patient¿s hospitalization, as it is unknown when the patient last underwent ccpd therapy.There is no allegation or objective evidence indicating a liberty select cycler deficiency or malfunction caused or contributed to the event(s).However, based on limited information available and the lack of specific details, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the patient¿s hospitalization.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

During a follow up call, it was reported that the patient had been in the hospital.Upon follow up with the patient¿s outpatient dialysis center, it was discovered that the patient was driving home from vacation, became ill (specifics not provided), and stopped at the closest hospital.The patient stayed approximately 2 days (exact dates not provided) and was discharged (specifics not provided).The discharge summary is currently not available.The patient returned home, but was hospitalized again (date and specifics not provided) and currently remains hospitalized.The admitting diagnosis for either hospitalization was not provided, however the outpatient dialysis center reported that the hospitalizations were for the same reason.The discharge summary and additional patient information was requested; however, the request was declined.The current disposition of the patient is unknown, and subsequent attempts to gather additional information have thus far proven unsuccessful.

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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8905555
• MDR Text Key: 154717424
• Report Number: 2937457-2019-02624
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 08/27/2019
• 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; Required Intervention