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

Catalog Number RTLR180343

Device Problem Overfill (2404)

Patient Problems Memory Loss/Impairment (1958); Uremia (2188); Weight Changes (2607)

Event Date 11/12/2018

Event Type  Injury  

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.Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler and the patient event of fluid volume overload with uremia and cognitive impairment.The uremia which is due to insufficient dialysis is most likely the cause of the patient¿s confusion and memory issues.There is a possible causal relationship between the liberty select cycler and the adverse event as the patient reported unspecified issues with the liberty select cycler which prevented him from completing ccpd therapy.A machine evaluation has not been completed at the time of this clinical investigation and there are no treatment records for review, therefore it cannot be confirmed if any malfunction occurred.Based on the available information the cause of the event cannot be confirmed.

Event Description

On (b)(6) 2018 during follow up for a separate issue, the peritoneal dialysis registered nurse (pdrn) for this male patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported the patient was hospitalized (b)(6) 2018.The patient was hospitalized for fluid volume overload with a weight gain of seventeen pounds (unknown time period) with uremia, concentration issues and short-term memory loss.The patient had stated they were having unspecified issues with the fresenius liberty select cycler and could not get past dwell three.The patient was discharged (b)(6) 2018.The pdrn reported that the cycler issues could not be confirmed.The hospital course is unknown.

Manufacturer Narrative

Changed product problem to yes.(b)(4).

• 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: 8195472
• MDR Text Key: 131373349
• Report Number: 2937457-2018-03725
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• 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: 12/26/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 12/26/2018
• 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
• Patient Age: 53 YR
• Patient Weight: 83