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

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the patient¿s possible exacerbation of a preexisting inguinal hernia (characterized by abdominal discomfort).There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned and/or failed to meet the users¿ expectations or manufacturers¿ specifications.However, the liberty select cycler cannot be excluded from having a possible contributory role in the probable exacerbation of the patient¿s inguinal hernia.While the patient¿s inguinal hernia predated ccpd therapy, the abdominal inguinal hernia pain experienced by the patient appears to have grown worse in recent days.It should be noted that minimal additional information was obtained, which precluded a more comprehensive investigation.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.

Event Description

On 11/jan/2024 during follow-up, 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) mentioned having inguinal hernia pain.No additional information was provided during intake.Follow-up documentation received from the patient¿s outpatient home dialysis clinic revealed the patient¿s inguinal hernia present prior to the patient beginning pd therapy.It was stated the surgeon was aware of the hernia and elected not to intervene during a pd catheter placement (date not provided).The patient was informed the hernia would require surgery; however, the patient became ill, and it was postponed.It is unknown if the hernia worsened while the patient was undergoing ccpd therapy.

Manufacturer Narrative

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

On (b)(6) 2024 during follow-up, 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) mentioned having inguinal hernia pain.No additional information was provided during intake.Follow-up documentation received from the patient¿s outpatient home dialysis clinic revealed the patient¿s inguinal hernia present prior to the patient beginning pd therapy.It was stated the surgeon was aware of the hernia and elected not to intervene during a pd catheter placement (date not provided).The patient was informed the hernia would require surgery; however, the patient became ill, and it was postponed.It is unknown if the hernia worsened while the patient was undergoing ccpd therapy.

• 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: 18546238
• MDR Text Key: 333278650
• Report Number: 0002937457-2024-00114
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 64 KG