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 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of bilateral umbilical hernias.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned or failed to meet the users¿ expectations.However, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the exacerbation of the patient¿s umbilical hernias.Per the pdrn, the patient¿s bilateral umbilical hernias were present prior to the patient 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 (not a fresenius product) also increases the risk of hernia formation.Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A patient's spouse reported a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) noted blood in the drain line during treatment on (b)(6) 2023.The patient¿s spouse reported the patient recently underwent surgery to repair two hernias.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient had been experiencing drain complications on/off for the last several months, and radiological studies determined the patient¿s bilateral umbilical hernias (existed prior to patient beginning pd) had grown in size and were obstructing the pd catheter (not a fresenius product).Therefore, the nephrologist ordered the patient to undergo outpatient umbilical hernia surgery on (b)(6) 2023.The patient was discharged following the procedure and was told to withhold pd therapy until (b)(6) 2023.The patient resumed ccpd therapy on (b)(6) 2023, and the blood noted in the patient¿s drain line during treatment was considered normal given the patient¿s recent surgery (resolved without intervention).The patient is recovering from the events and continues to utilize the same cycler as before.The pdrn reported the patient¿s umbilical hernias were present prior to the patient beginning pd therapy, however ccpd therapy likely assisted in the exacerbation of the hernias.Per the pdrn, there was no malfunction of deficiency of a fresenius device(s) and/or product(s) to report.

• 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: 18136480
• MDR Text Key: 328111895
• Report Number: 0002937457-2023-01708
• 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: K181108
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 10/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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: Male