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)

Event Date 11/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, fresenius became aware this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) experienced difficulty breathing (dyspnea) and a feeling of fullness.The patient emergently discontinued ccpd therapy and was taken to the hospital.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room (er) on (b)(6) 2022 with complaints of dyspnea and ¿feeling full.¿ the pdrn stated the patient was admitted for fluid overload (confirmed via chest x-ray) due to the patient¿s non-compliance with dietary restrictions, fluid intake and refuses to perform his prescribed mid-day exchange.While hospitalized it was also determined the patient was not accurately altering which strength delflex (1.5%, 2.5% or 4.25%) he utilized based on his weight.The patient underwent multiple ccpd treatments utilizing only 2.5% and 4.25% to increase ultrafiltration and was discharged on 21/nov/2022 in stable condition.The pdrn reported there was no overfill event, and the patient¿s abdomen was not drained prior to his transportation to the er which accounts for the fluid in their abdomen.The patient¿s dyspnea and fluid overload were corrected with the alteration in pd prescription, and post-hospitalization home training was performed.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

Manufacturer Narrative

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

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of fluid overload (characterized by dyspnea and feeling full), which required hospitalization.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient¿s non-compliance with fluid intake, dietary restrictions, midday exchanges, and the improper incorporation of higher dextrose solutions, when increased ultrafiltration (uf) is required.The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Fluid overload is a well-known potential complication of the end state renal dialysis (esrd) process.Causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure.Additionally, patient related factors such as non-compliance (unintentional or otherwise) can be a significant contributing factor, thus limiting the efficacy of renal replacement therapy (rrt).Based on the information available, the patient¿s liberty select cycler can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet user expectations or manufacturer specifications.

Event Description

On 21/nov/2022, fresenius became aware this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) experienced difficulty breathing (dyspnea) and a feeling of fullness.The patient emergently discontinued ccpd therapy and was taken to the hospital.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room (er) on (b)(6) 2022 with complaints of dyspnea and ¿feeling full.¿ the pdrn stated the patient was admitted for fluid overload (confirmed via chest x-ray) due to the patient¿s non-compliance with dietary restrictions, fluid intake and refuses to perform his prescribed mid-day exchange.While hospitalized it was also determined the patient was not accurately altering which strength delflex (1.5%, 2.5% or 4.25%) he utilized based on his weight.The patient underwent multiple ccpd treatments utilizing only 2.5% and 4.25% to increase ultrafiltration and was discharged on (b)(6) 2022 in stable condition.The pdrn reported there was no overfill event, and the patient¿s abdomen was not drained prior to his transportation to the er which accounts for the fluid in their abdomen.The patient¿s dyspnea and fluid overload were corrected with the alteration in pd prescription, and post-hospitalization home training was performed.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

Event Description

On 21/nov/2022, fresenius became aware this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) experienced difficulty breathing (dyspnea) and a feeling of fullness.The patient emergently discontinued ccpd therapy and was taken to the hospital.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room (er) on (b)(6) 2022 with complaints of dyspnea and ¿feeling full.¿ the pdrn stated the patient was admitted for fluid overload (confirmed via chest x-ray) due to the patient¿s non-compliance with dietary restrictions, fluid intake and refuses to perform his prescribed mid-day exchange.While hospitalized it was also determined the patient was not accurately altering which strength delflex (1.5%, 2.5% or 4.25%) he utilized based on his weight.The patient underwent multiple ccpd treatments utilizing only 2.5% and 4.25% to increase ultrafiltration and was discharged on (b)(6) 2022 in stable condition.The pdrn reported there was no overfill event, and the patient¿s abdomen was not drained prior to his transportation to the er which accounts for the fluid in their abdomen.The patient¿s dyspnea and fluid overload were corrected with the alteration in pd prescription, and post-hospitalization home training was performed.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

Manufacturer Narrative

Correction: d8, b3, h6.

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.There were visual indications of dried fluid within the cassette compartment.There was no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.An as received simulated treatment with reduced dwell times was performed and completed without any failures or problems.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak test, valve actuation test, teach pump test, and patient sensor calibration check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.There were visual indications of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump assembly.The cause of the observed dried fluid and fluid could not be determined.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.

Event Description

On 21/nov/2022, fresenius became aware this 63-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) experienced difficulty breathing (dyspnea) and a feeling of fullness.The patient emergently discontinued ccpd therapy and was taken to the hospital.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room (er) on (b)(6) 2022 with complaints of dyspnea and ¿feeling full.¿ the pdrn stated the patient was admitted for fluid overload (confirmed via chest x-ray) due to the patient¿s non-compliance with dietary restrictions, fluid intake and refuses to perform his prescribed mid-day exchange.While hospitalized it was also determined the patient was not accurately altering which strength delflex (1.5%, 2.5% or 4.25%) he utilized based on his weight.The patient underwent multiple ccpd treatments utilizing only 2.5% and 4.25% to increase ultrafiltration and was discharged on (b)(6) 2022 in stable condition.The pdrn reported there was no overfill event, and the patient¿s abdomen was not drained prior to his transportation to the er which accounts for the fluid in their abdomen.The patient¿s dyspnea and fluid overload were corrected with the alteration in pd prescription, and post-hospitalization home training was performed.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

• 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: 15934294
• MDR Text Key: 305012691
• Report Number: 0002937457-2022-02111
• 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,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 03/16/2023; 03/27/2023
• Supplement Dates FDA Received: 12/14/2022; 03/24/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male