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

Model Number UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)

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

Patient Problem Heart Failure (2206)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

During routine follow up on an unrelated customer experience it was indicated that the peritoneal dialysis patient was hospitalized for acute and chronic systolic heart failure on an unspecified date.There is no allegation of a device malfunction contributing to the patient¿s hospitalization.Additional information was solicited.

Event Description

Additional information was received and evaluated.

Manufacturer Narrative

Clinical review; discharge summary was received and reviewed for new information pertaining to this hospitalization.According to the records, the patient was hospitalized (b)(6) 2018 through (b)(6) 2018 for acute on chronic systolic heart failure and was found to have cardiorenal syndrome.Prior to the hospitalization the patient was not on dialysis, however, due to the patient¿s condition, peritoneal dialysis (pd) was initiated on (b)(6) 2018 after placement of pd catheter (not a fresenius product).The dialysis improved the patient¿s condition.This hospitalization was not related to any pd therapy on the liberty cycler.The completion of a clinical investigation is not required.A supplemental mdr with plant investigation will not be submitted since this event has been determined to not be a reportable event related to fresenius products.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7611309
• MDR Text Key: 111402398
• Report Number: 2937457-2018-01712
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention