MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN- 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 Problems Abdominal Pain (1685); Hernia (2240)

Event Date 01/01/2020

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: there is a potential temporal relationship between pd therapy utilizing the liberty cycler and the patient event of hernia with surgical repair and transition to hd therapy.However, there is no documentation in the complaint file to show a causal relationship between the hernia and utilization of the liberty cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for the hernia event.It was documented that the hernia was not related to any fresenius device or product.Patients on pd are at risk of developing hernia due to increased stress on the abdominal muscles from the dialysate and the opening in the muscle created by the pd catheter placement.Although it is unknown if pd therapy itself contributed to the hernia, there is no allegation of a device malfunction or deficiency or other fresenius product(s) causing the patient¿s hernia.Based on the available information and no allegation or evidence of a malfunction or deficiency, the liberty cycler can be excluded as the cause of the hernia.

Event Description

During a response to a customer survey, this patient had reported staying on in-center dialysis due to losing the canula as a result of a hernia.Additional information was provided by the clinic manager.The patient presented to the emergency room (er) on an unknown date due to abdominal pain.The patient was diagnosed with a hernia.The hernia was unknown to the patient prior to the er visit.The patient underwent a hernia repair (date unknown).The patient¿s peritoneal dialysis (pd) catheter was removed, and the patient was transitioned to in-center hemodialysis (hd) without complication.The patient remains on in-center hd to date.It is unknown if the hernia was pre-existing prior to the initiation of pd therapy.The patient was initiated on pd therapy on (b)(6) 2019.The cause of the hernia was not provided; however, it was documented that the hernia was not related to any fresenius device(s) or product(s).

• Brand Name: UNKNOWN- 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: 14578121
• MDR Text Key: 293342268
• Report Number: 0002937457-2022-00882
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/02/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG