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 Chest Pain (1776); Hypervolemia (2664)

Event Date 01/29/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On (b)(6) 2023, during a follow up, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius they were hospitalized for fluid retention.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following chest pain experienced during a ccpd treatment on the liberty select cycler at home.The patient recently experienced a myocardial infarction that was unrelated to pd therapy, and he has a high level of anxiety concerning perceived cardiac symptoms.The patient was diagnosed with fluid overload attributed to preexisting cardiac disease and the use of inappropriate dialysate solutions when symptoms presented.It was explained the patient typically uses 2.5% delflex but has been advised by his nephrologist to use 4.25% when the patient feels they have too much fluid.The patient has been fearful concerning the use of 4.25% delflex at will only use 2.5% regardless of the presentation of cardiac symptoms.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The patient recovered from this event as he remains asymptomatic.It was confirmed the patient¿s chest pain, fluid overload, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

Event Description

On 31/jan/2023, during a follow up, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius they were hospitalized for fluid retention.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following chest pain experienced during a ccpd treatment on the liberty select cycler at home.The patient recently experienced a myocardial infarction that was unrelated to pd therapy, and he has a high level of anxiety concerning perceived cardiac symptoms.The patient was diagnosed with fluid overload attributed to preexisting cardiac disease and the use of inappropriate dialysate solutions when symptoms presented.It was explained the patient typically uses 2.5% delflex but has been advised by his nephrologist to use 4.25% when the patient feels they have too much fluid.The patient has been fearful concerning the use of 4.25% delflex at will only use 2.5% regardless of the presentation of cardiac symptoms.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The patient recovered from this event as he remains asymptomatic.It was confirmed the patient¿s chest pain, fluid overload, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

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.

Manufacturer Narrative

Correction: h10 clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler and the adverse event of fluid overload, characterized by chest pain.It is well established for patients that have both cardiac and renal dysfunction are at high risk for fluid imbalance and its deleterious effects.The root cause of this patient¿s fluid overload can be attributed to preexisting cardiac disease and the patient¿s use of inappropriate dialysate strength when cardiac symptoms present as reported by a medical professional.Fluid overload, or cardiopulmonary congestion, complicates fluid removal due to the inadequacy to efficiently remove fluid systemically.This is complicated by the reintroduction of fluid in the form of dialysate, fluid restriction and/or intake and diuretic use depending on residual renal function.Therefore, the liberty select cycler can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

On (b)(6) 2023, during a follow up, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius they were hospitalized for fluid retention.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following chest pain experienced during a ccpd treatment on the liberty select cycler at home.The patient recently experienced a myocardial infarction that was unrelated to pd therapy, and he has a high level of anxiety concerning perceived cardiac symptoms.The patient was diagnosed with fluid overload attributed to preexisting cardiac disease and the use of inappropriate dialysate solutions when symptoms presented.It was explained the patient typically uses 2.5% delflex but has been advised by his nephrologist to use 4.25% when the patient feels they have too much fluid.The patient has been fearful concerning the use of 4.25% delflex at will only use 2.5% regardless of the presentation of cardiac symptoms.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The patient recovered from this event as he remains asymptomatic.It was confirmed the patient¿s chest pain, fluid overload, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

• 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: 16425137
• MDR Text Key: 310043246
• Report Number: 0002937457-2023-00267
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 123 KG