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 Problems Hernia (2240); Swelling/ Edema (4577)

Event Date 12/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2023 this patient on peritoneal dialysis (pd) reported they had a hernia.Therefore, more follow-up was performed with the patient¿s pd nurse.It was reported that the patient began pd therapy in (b)(6) 2021.Per the nurse, it is believed the patient developed an abdominal hernia after start of pd treatment.However, the nurse indicated this could not be confirmed.It was stated the patient developed symptoms of swelling.As a result, in (b)(6) 2022 (exact date not provided), the patient required repair of the abdominal hernia.However, per the nurse, the patient continued to experience symptoms of swelling with the hernia.Therefore, the patient had the prescribed fill volume reduced from 2000 ml to 1800 ml.The nurse indicated the patient is scheduled to see the surgeon again (date not provided) to evaluate for an additional repair.The nurse confirmed the patient has not had any adverse effects from use of any fresenius device, or product.Additionally, the nurse provided there were no cycler malfunctions or increased intra-peritoneal volume (iipv) events related to the reported hernia.The nurse stated the swelling/hernia was likely due to the normal physiology of pd treatment.The patient reportedly continues pd treatment on the same cycler without any adverse effects.

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 peritoneal dialysis (pd) therapy with the liberty select cycler and the patient¿s abdominal hernia (characterized by swelling) which required subsequent repair.Hernia is a well-documented complication in pd patient¿s due to an expected increased intra-abdominal pressure from the dialysate during pd treatment.Nonetheless, the concomitant use of the fresenius cycler to facilitate dialysis cannot be excluded as a contributory factor in the event.However, currently there is no reported allegation or objective evidence that a liberty select cycler malfunction or product deficiency caused serious harm to the patient.

Event Description

On 24/jan/2023, this patient on peritoneal dialysis (pd) reported they had a hernia.Therefore, more follow-up was performed with the patient¿s pd nurse.It was reported that the patient began pd therapy in (b)(6) of 2021.Per the nurse, it is believed the patient developed an abdominal hernia after start of pd treatment.However, the nurse indicated this could not be confirmed.It was stated the patient developed symptoms of swelling.As a result, in (b)(6) 2022 (exact date not provided), the patient required repair of the abdominal hernia.However, per the nurse, the patient continued to experience symptoms of swelling with the hernia.Therefore, the patient had the prescribed fill volume reduced from 2000 ml to 1800 ml.The nurse indicated the patient is scheduled to see the surgeon again (date not provided) to evaluate for an additional repair.The nurse confirmed the patient has not had any adverse effects from use of any fresenius device, or product.Additionally, the nurse provided there were no cycler malfunctions or increased intra-peritoneal volume (iipv) events related to the reported hernia.The nurse stated the swelling/hernia was likely due to the normal physiology of pd treatment.The patient reportedly continues pd treatment on the same cycler without any adverse effects.

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: 16357165
• MDR Text Key: 309366876
• Report Number: 0002937457-2023-00205
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2011
• 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: 70 YR
• Patient Sex: Female