MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- LIBERTY CYCLER UL

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

Patient Problem Dehydration (1807)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Clinical investigation: it was reported during followup that the patient was hospitalized (date unknown) for dehydration due to patient non-compliance with the pd prescription.It was confirmed the hospitalization was not related to any issues with a fresenius device, or product.Upon review of the available information, there is no allegation or objective evidence that the patient had an adverse event related to an issue with fresenius products.

Event Description

A nurse reported to fresenius that the peritoneal dialysis (pd) patient was hospitalized (date unknown) for dehydration due to patient non-compliance with the pd prescription.It was confirmed the hospitalization was not related to any issues with a fresenius device, or product.The patient is currently on hemodialysis, and it was stated the patient did not have any adverse effects due to fresenius products.

• Brand Name: LIBERTY CYCLER UL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15520878
• MDR Text Key: 301009395
• Report Number: 0002937457-2022-01631
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention