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 Problem Myocardial Infarction (1969)

Event Date 12/04/2023

Event Type  Death  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s mi, leading to her death.The cause of this patient¿s death can be attributed to an mi with no indication of fresenius product or device involvement as reported by a medical professional.It is well known the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population, particularly in the environment of cardiovascular disease.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 is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse events.Should additional information become available, the file will be reassessed and updated accordingly.

Event Description

On (b)(6) 2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service this pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler expired while connected to the cycler.There was no specific allegation this 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 pdrn, it was reported this patient expired on (b)(6) 2023 at home due to a myocardial infarction (mi) attributed to multimorbidity.It was unknown if emergency services were activated but it was affirmed the patient was pronounced deceased in their residence and they were transported directly to the funeral home.The patient was connected to their liberty select cycler at the time of their mi and subsequent death.It was confirmed the patient¿s mi leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

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

On (b)(6) 2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service this pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler expired while connected to the cycler.There was no specific allegation this 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 pdrn, it was reported this patient expired on (b)(6) 2023 at home due to a myocardial infarction (mi) attributed to multimorbidity.It was unknown if emergency services were activated but it was affirmed the patient was pronounced deceased in their residence and they were transported directly to the funeral home.The patient was connected to their liberty select cycler at the time of their mi and subsequent death.It was confirmed the patient¿s mi leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

Plant investigation: the cycler was returned for evaluation.An exterior visual inspection of the returned cycler showed no sign of physical damage.An (as-received with reduced dwell) simulated treatment was performed and completed without any failures or problems.The system air leak test passed.The valve actuation test, teach pump test and patient sensor check passed.An internal visual inspection of the returned cycler encountered no discrepancies.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.

Event Description

On 5/dec/2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service this pd patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler expired while connected to the cycler.There was no specific allegation this 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 pdrn, it was reported this patient expired on (b)(6) 2023 at home due to a myocardial infarction (mi) attributed to multimorbidity.It was unknown if emergency services were activated but it was affirmed the patient was pronounced deceased in their residence and they were transported directly to the funeral home.The patient was connected to their liberty select cycler at the time of their mi and subsequent death.It was confirmed the patient¿s mi leading to their death was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

• 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: 18291754
• MDR Text Key: 330052235
• Report Number: 0002937457-2023-01846
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 107 KG