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

Catalog Number RTLR180343

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

Patient Problem Hernia (2240)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Plant investigation: 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 select cycler, and the patient¿s serious adverse events of an inguinal hernia.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned or failed to meet the manufacturers¿ specifications.However, the liberty select cycler cannot be excluded from having a probable causal/contributory role in the creation and/or exacerbation of the inguinal hernia.Per the pdrn, the patient¿s umbilical hernia was not present prior to her beginning pd for rrt.Hernias are a recognized complication of pd therapy (manual or cycler based) due to the increased intra-abdominal pressure created during pd therapy.During therapy, this pressure can create and/or exacerbate weaknesses in the supporting abdominal wall structures.Additionally, the surgical introduction of the pd catheter required for therapy also increases the risk of hernia formation.

Event Description

On 20/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was diagnosed with a hernia.No additional information provided during intake.Further follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient had been experiencing drain complications (intermittently), and the nephrologist ordered radiological testing to assess the pd catheters¿ (not a fresenius product) placement.X-rays revealed the patient¿s pd catheter was properly positioned; however, a right-sided inguinal hernia was discovered.Currently the patient is delaying any surgical intervention, as the drain complications are intermittent.The patient continues to utilize the same liberty select cycler without reported issue.The pdrn stated the patient¿s inguinal hernia was not present prior to her beginning pd therapy, and despite the pdrn reporting there were no fresenius device or product malfunctions noted, ccpd therapy likely assisted in the creation and/or exacerbation of the inguinal hernia.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• 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: 18942772
• MDR Text Key: 338148691
• Report Number: 0002937457-2024-00480
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222318
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2010
• 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: LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 54 KG