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

Catalog Number RTLR180343

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

Patient Problems Abdominal Distention (2601); Hypervolemia (2664)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the adverse events of fluid overload and fluid retention, characterized by fullness and abdominal distention.The patient¿s fluid overload and retention can be attributed to drain complications during pd therapy; however, the etiology of the patient¿s drain complications remain unknown as reported by a medical professional.It is well established pd patients are susceptible to fluid volume overload due to multiple intrinsic causes and it is experienced by more male pd patients than women.Regardless, in the absence of a confirmed source of the patient¿s fluid overload and fluid retention, the liberty select cycler cannot be excluded as a potential root cause or contributor to this patient¿s adverse events.Based on the available information, though there was an inferred allegation this event was related to the performance of the liberty select cycler, there is no objective evidence that any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse events.

Event Description

On (b)(6) 2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius technical services this pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized twice for fluid overload.There was an inferred allegation these events were related to the performance of the liberty select cycler in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2023 following abdominal distention and fullness upon discontinuation of a ccpd treatment on the liberty select cycler at home.The patient was diagnosed with fluid overload due to drain complications during pd therapy.The patient was manually drained in the hospital.The patient underwent testing to determine causality of the drain complications to include cardiac testing and pd catheter (not a fresenius product) evaluation.All tests conducted in the hospital resulted within normal limits and the root cause of the patient¿s drain complications remained unknown.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) without incident for the duration of the admission.The patient had an uneventful hospital course and was discharged home on (b)(6) 2023.The patient resumed ccpd therapy on his home liberty select cycler on the evening of (b)(6) 2023 and had to discontinue the treatment on the morning of (b)(6) 2023 due to abdominal distention and fullness.The patient returned to the hospital on the morning of (b)(6) 2023 where he was diagnosed with fluid retention following a pd treatment due to drain complications of unknown etiology.The patient was drained in the hospital.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.It was affirmed that the patient did not experience a serious injury as a result of the fluid overload or retention.The pdrn denied any specific malfunction or deficiency with the patient¿s cycler; however, a new cycler was requested to potentially rule out cycler involvement with the patient¿s drain complications.The pdrn denied any notable alarms on the patient¿s cycler or previous occurrences of fluid overload or retention.The pdrn denied any patient comorbidities that could potentially cause or contribute to these events.It could not be confirmed whether there was fresenius product(s) or device(s) involvement with the patient¿s drain complications as the root cause of these events remain unknown.The patient recovered from these events and continues ccpd therapy on a newly received liberty select cycler at home post-discharge without further incident.

Event Description

On (b)(6) 2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius technical services this pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler was hospitalized twice for fluid overload.There was an inferred allegation these events were related to the performance of the liberty select cycler in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2023 following abdominal distention and fullness upon discontinuation of a ccpd treatment on the liberty select cycler at home.The patient was diagnosed with fluid overload due to drain complications during pd therapy.The patient was manually drained in the hospital.The patient underwent testing to determine causality of the drain complications to include cardiac testing and pd catheter (not a fresenius product) evaluation.All tests conducted in the hospital resulted within normal limits and the root cause of the patient¿s drain complications remained unknown.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) without incident for the duration of the admission.The patient had an uneventful hospital course and was discharged home on (b)(6) 2023.The patient resumed ccpd therapy on his home liberty select cycler on the evening of (b)(6) 2023 and had to discontinue the treatment on the morning of (b)(6) 2023 due to abdominal distention and fullness.The patient returned to the hospital on the morning of 23/oct/2023 where he was diagnosed with fluid retention following a pd treatment due to drain complications of unknown etiology.The patient was drained in the hospital.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.It was affirmed that the patient did not experience a serious injury as a result of the fluid overload or retention.The pdrn denied any specific malfunction or deficiency with the patient¿s cycler; however, a new cycler was requested to potentially rule out cycler involvement with the patient¿s drain complications.The pdrn denied any notable alarms on the patient¿s cycler or previous occurrences of fluid overload or retention.The pdrn denied any patient comorbidities that could potentially cause or contribute to these events.It could not be confirmed whether there was fresenius product(s) or device(s) involvement with the patient¿s drain complications as the root cause of these events remain unknown.The patient recovered from these events and continues ccpd therapy on a newly received liberty select cycler at home post-discharge without further incident.

Manufacturer Narrative

Additional information provided in d9 and h3.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.There were visual indications of dried fluid within the cassette compartment on the pump door and on the top cover.There was a visual indication of particulates around the catch post area and within cassette compartment.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.A post-accelerated stress test 2 hour 15 min 8500 ml simulated treatment was performed and completed without any failures or problems.The cycler programmed displayed drain and fill volume values were within the tolerances.A drain complication encountered support warning occurred, as expected, when the patient line was clamped during the dwell phase, cycle 0.The cycler underwent and passed a system air leak test and valve actuation test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.There were visual indications of dried fluid found in between the pump assembly and display assembly during internal inspection.There was visual evidence of a clog in hp1 and hp3 filter.There were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump during internal inspection.The cause of the dried fluid could not be determined.A review of the device manufacturing records was conducted by the manufacturer.No deviations or non-conformances during the manufacturing process.In addition, a device history record review was performed and verified that the results of the in-progress and final quality control 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: 18144662
• MDR Text Key: 328224818
• Report Number: 0002937457-2023-01717
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG