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 01/01/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler, and the patient¿s adverse event(s) of swelling and hernia (type unknown), which warranted the transition of modality from ccpd to hd for rrt.While there is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction occurred.The liberty cycler cannot be excluded from having a possible contributory role in the swelling and/or creation/exacerbation of the patient¿s hernia.Hernias are a well-known potential complication of pd therapy due to increased intra-abdominal pressure created during pd therapy.During therapy, this pressure caused can create or exacerbate weaknesses in the supporting abdominal wall structures.Additionally, the surgical introduction of the pd catheter (not a fresenius product) also increases the risk of hernia formation.

Event Description

During an anonymous customer experience survey, it was reported that this customer was on peritoneal dialysis (pd) and experienced swelling and a possible hernia.There were no recorded issues with a fresenius device, or product in relation to the reported event.Additional information was requested, however to date has not been provided.

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.

Event Description

During an anonymous customer experience survey, it was reported that this customer was on peritoneal dialysis (pd) and experienced swelling and a possible hernia.There were no recorded issues with a fresenius device, or product in relation to the reported event.Additional information was requested, however to date has not been provided.

• 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: 15438254
• MDR Text Key: 300048434
• Report Number: 0002937457-2022-01516
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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: 10/08/2021
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET .
• Patient Outcome(s): Required Intervention