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 Weight Changes (2607); Hypervolemia (2664)

Event Date 03/09/2023

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient reported being hospitalized on (b)(6), 2021 for fluid volume overload (characterized by approximately 15 pound weight gain).In additional follow up, the hospitalization event was confirmed with the patient¿s pd nurse.The nurse provided that the patient did not have any other symptoms of fluid volume overload other than the reported 15 pound weight gain.The patient was seen by primary doctor (for a routine visit) on (b)(6), 2023 and then sent to the hospital later the same day.The patient has pre-existing heart failure and the patient is on oral diuretic at home.Additionally, the patient was on an increased dose of prednisone (side effect is weight gain) for pre-existing sarcoidosis.The nurse stated the patient¿s primary doctor wanted the patient to be admitted to the hospital for intravenous (iv) diuretic and ultrafiltration with pd therapy.The nurse stated the patient¿s pd prescription was changed from 2.5% to 4.25% with an extra pd exchange in the hospital.The nurse did not have any further dialysis treatment information from the hospital available.The patient remained hospitalized at the time follow-up was completed.The nurse indicated the patient had been completing pd treatment on the cycler without any adverse effects prior to the hospitalization.The cycler is not suspected to be malfunctioning, per the nurse.

Manufacturer Narrative

Clinical review: a temporal relationship exists between pd therapy with the liberty select cycler and the patient¿s hospitalization for fluid volume overload.Fluid volume overload is a common complication in patients with end stage renal disease (esrd) on dialysis.The patient has pre-existing comorbid condition of sarcoidosis for which the patient was prescribed and increased dose of prednisone.A common side effect of prednisone is weight gain.Additionally, the patient has pre-existing heart failure and is prescribed diuretic therapy which are medications used for managing extra fluid in the body.Currently, there is no allegation or objective evidence that a liberty select cycler malfunction or product issue caused this event.The patient¿s hospitalization for fluid volume overload is likely multifactorial in nature given the patient¿s pre-existing conditions, and medication regimen.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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

A peritoneal dialysis (pd) patient reported being hospitalized on (b)(6) 2021 for fluid volume overload (characterized by approximately 15 pound weight gain).In additional follow up, the hospitalization event was confirmed with the patient¿s pd nurse.The nurse provided that the patient did not have any other symptoms of fluid volume overload other than the reported 15 pound weight gain.The patient was seen by primary doctor (for a routine visit) on (b)(6) 2023 and then sent to the hospital later the same day.The patient has pre-existing heart failure and the patient is on oral diuretic at home.Additionally, the patient was on an increased dose of prednisone (side effect is weight gain) for pre-existing sarcoidosis.The nurse stated the patient¿s primary doctor wanted the patient to be admitted to the hospital for intravenous (iv) diuretic and ultrafiltration with pd therapy.The nurse stated the patient¿s pd prescription was changed from 2.5% to 4.25% with an extra pd exchange in the hospital.The nurse did not have any further dialysis treatment information from the hospital available.The patient remained hospitalized at the time follow-up was completed.The nurse indicated the patient had been completing pd treatment on the cycler without any adverse effects prior to the hospitalization.The cycler is not suspected to be malfunctioning, per the nurse.

• 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: 16628977
• MDR Text Key: 312145022
• Report Number: 0002937457-2023-00468
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male