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 Dyspnea (1816); Hypervolemia (2664); Insufficient Information (4580)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.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) 2023, a patient contact reported to fresenius technical services this (b)(6) female peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized due to drain complications during pd therapy.There was an inferred allegation this event was related to the performance of the liberty select cycler 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 due to an exacerbation of preexisting systolic congestive heart failure (chf) leading to fluid overload.It was explained that the patient experienced drain and fill complications during ccpd therapy on the liberty select cycler at home prior to this hospitalization.The patient¿s drain and fill complications were due to unknown etiology as the patient¿s pd catheter (not a fresenius product) has not been evaluated.Additionally, there was no evidence these complications were related to the performance of her cycler.The patient did not alert the outpatient clinic of these complications and opted to skip pd therapy for two days which led to chf exacerbation.It was affirmed the patient is trained on manual exchanges and had the required product(s) at home to undergo continuous ambulatory pd as an alternative to her cycler.The patient experienced dyspnea and generalized weakness after two missed pd treatments which prompted the hospitalization.It was further explained that the patient has a very tenuous heart with an ejection fraction of 20% (as demonstrated by ultrasound during this hospitalization) and she is very sensitive to systemic fluid changes.The patient has been able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the patient¿s missed treatments caused the chf exacerbation and fluid overload, there was no indication the patient¿s diagnoses, associated symptoms and hospitalization were related to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy at home upon discharge, but a new cycler has been requested by the patient.

Event Description

On 4/jun/2023, a patient contact reported to fresenius technical services this 49-year-old female peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized due to drain complications during pd therapy.There was an inferred allegation this event was related to the performance of the liberty select cycler 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 due to an exacerbation of preexisting systolic congestive heart failure (chf) leading to fluid overload.It was explained that the patient experienced drain and fill complications during ccpd therapy on the liberty select cycler at home prior to this hospitalization.The patient¿s drain and fill complications were due to unknown etiology as the patient¿s pd catheter (not a fresenius product) has not been evaluated.Additionally, there was no evidence these complications were related to the performance of her cycler.The patient did not alert the outpatient clinic of these complications and opted to skip pd therapy for two days which led to chf exacerbation.It was affirmed the patient is trained on manual exchanges and had the required product(s) at home to undergo continuous ambulatory pd as an alternative to her cycler.The patient experienced dyspnea and generalized weakness after two missed pd treatments which prompted the hospitalization.It was further explained that the patient has a very tenuous heart with an ejection fraction of 20% (as demonstrated by ultrasound during this hospitalization) and she is very sensitive to systemic fluid changes.The patient has been able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the patient¿s missed treatments caused the chf exacerbation and fluid overload, there was no indication the patient¿s diagnoses, associated symptoms and hospitalization were related to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy at home upon discharge, but a new cycler has been requested by the patient.

Event Description

On 4/jun/2023, a patient contact reported to fresenius technical services this 49-year-old female peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized due to drain complications during pd therapy.There was an inferred allegation this event was related to the performance of the liberty select cycler 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 due to an exacerbation of preexisting systolic congestive heart failure (chf) leading to fluid overload.It was explained that the patient experienced drain and fill complications during ccpd therapy on the liberty select cycler at home prior to this hospitalization.The patient¿s drain and fill complications were due to unknown etiology as the patient¿s pd catheter (not a fresenius product) has not been evaluated.Additionally, there was no evidence these complications were related to the performance of her cycler.The patient did not alert the outpatient clinic of these complications and opted to skip pd therapy for two days which led to chf exacerbation.It was affirmed the patient is trained on manual exchanges and had the required product(s) at home to undergo continuous ambulatory pd as an alternative to her cycler.The patient experienced dyspnea and generalized weakness after two missed pd treatments which prompted the hospitalization.It was further explained that the patient has a very tenuous heart with an ejection fraction of 20% (as demonstrated by ultrasound during this hospitalization) and she is very sensitive to systemic fluid changes.The patient has been able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the patient¿s missed treatments caused the chf exacerbation and fluid overload, there was no indication the patient¿s diagnoses, associated symptoms and hospitalization were related to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy at home upon discharge, but a new cycler has been requested by the patient.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.The cycler underwent and passed a system air leak test and a valve actuation test.An as received treatment was performed without any failures or problems.An internal visual inspection of the returned cycler encountered no discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 17188068
• MDR Text Key: 317723098
• Report Number: 0002937457-2023-00906
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• 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?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2019
• 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: DEFLEX PD FLUID; DEFLEX PD FLUID; DEFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female