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 Hernia (2240)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

A temporal relationship does not exist between ccpd therapy utilizing a liberty cycler and this adverse event, as the patient¿s hernia was diagnosed prior to her start on renal replacement therapy.It is well established for those patients undergoing pd therapy are at high risk for mechanical complication due to hernias of any etiology and are recommended for early surgical repair.The exact date and cause of this patient¿s hernia cannot be determined; however, it was affirmed this event occurred prior the patient¿s use of any fresenius product(s) or device(s).A majority of hernias occur prior to the start of pd therapy, and most can be safely repaired to continue successful pd therapy.Therefore, the liberty select cycler can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the available information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.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.

Event Description

Through a clinic survey a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy reported that pd therapy caused pressure that ¿pushed the colon out¿.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient and the patient¿s hemodialysis registered nurse [(hd)rn], it was reported this patient experienced a hernia (exact type of hernia unknown) ¿years ago¿ and prior to her start on renal replacement therapy (exact date of diagnosis unknown).It was reported the hernia caused complications involving pressure during pd therapy; however, the patient stated never having had a problem with the cycler itself.The hdrn did not believe this patient¿s prolapse was due to a deficiency or malfunction of the patient¿s cycler, rather this event was predicated by the patient¿s comorbidities.The hdrn was unaware of what comorbidity could have potentially caused or contributed to the patient¿s adverse event.It was affirmed the patient did not receive any medical intervention as a result of the pressure during pd therapy.Additionally, the patient opted not to have a surgical repair for the hernia.Instead, the patient transitioned to in-center hd therapy in 2020 due to the pressure experienced during pd and advancing age of patient.It was confirmed by both the patient and the patient¿s hdrn the adverse event of the patient¿s hernia was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues in-center hd therapy without incident.

• 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: 14712952
• MDR Text Key: 294249123
• Report Number: 0002937457-2022-00973
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 06/16/2022
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG