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

Model Number 180343

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

Patient Problem Hernia (2240)

Event Date 02/15/2023

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient reported that they recently had a hernia surgery/procedure and have been having issues with draining.Upon follow up, the pdrn confirmed the patient underwent outpatient (scheduled) inguinal hernia surgery on (b)(6)2023.The patient had been experiencing drain complications (timeline unclear) and outpatient radiological/diagnostic studies identified a left-sided inguinal hernia which was not present prior to the patient starting pd for renal replacement therapy (rrt).The patient successfully underwent the surgical hernia repair and was discharged later the same day in stable condition.The patient¿s fill volume was decreased to 1000 ml (was 2200 ml) for the next 15-30 days, and the patient continues to utilize the same liberty select cycler.The pdrn stated the patient¿s liberty select cycler functioned as intended, however its usage likely created or exacerbated the inguinal hernia.The cycler is not available to be returned to the manufacturer for physical evaluation.

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 select cycler, and the patient¿s adverse events of an inguinal hernia (characterized by drain complications), which required surgical intervention.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned or failed to meet user expectation/manufacturer specifications.However, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the creation and/or exacerbation of the patient¿s hernia.Per the pdrn, the patient¿s inguinal hernia was not present prior to 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.

Event Description

A peritoneal dialysis (pd) patient reported that they recently had a hernia surgery/procedure and have been having issues with draining.Upon follow up, the pdrn confirmed the patient underwent outpatient (scheduled) inguinal hernia surgery on (b)(6)2023.The patient had been experiencing drain complications (timeline unclear) and outpatient radiological/diagnostic studies identified a left-sided inguinal hernia which was not present prior to the patient starting pd for renal replacement therapy (rrt).The patient successfully underwent the surgical hernia repair and was discharged later the same day in stable condition.The patient¿s fill volume was decreased to 1000 ml (was 2200 ml) for the next 15-30 days, and the patient continues to utilize the same liberty select cycler.The pdrn stated the patient¿s liberty select cycler functioned as intended, however its usage likely created or exacerbated the inguinal hernia.The cycler is not available to be returned to the manufacturer for physical evaluation.

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.

• 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: 16438834
• MDR Text Key: 310229712
• Report Number: 0002937457-2023-00285
• 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,Followup
• Report Date: 03/20/2023

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 Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2011
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 74 KG