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 11/21/2023

Event Type  Death  

Event Description

On 28/nov/2023, a peritoneal dialysis registered nurse ((pd)rn) reported to fresenius customer service this 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 at home on (b)(6) 2023 due to a myocardial infarction (mi).It was affirmed the patient was connected to his liberty select cycler at the time of the mi and subsequent death.The patient was found unresponsive by family at home and emergency services were activated but the patient was pronounced deceased with no hospital transport.It was unknown whether that patient had any significant cardiac comorbidities that may have contributed to the mi, but it was stated the patient was morbidly obese with difficulty ambulating and they were tachycardic at baseline.It was confirmed the patient¿s mi, and subsequent death were not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient¿s mi, leading to their 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.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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On (b)(6) 2023, a peritoneal dialysis registered nurse ((pd)rn) reported to fresenius customer service this 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 at home on (b)(6) 2023 due to a myocardial infarction (mi).It was affirmed the patient was connected to his liberty select cycler at the time of the mi and subsequent death.The patient was found unresponsive by family at home and emergency services were activated but the patient was pronounced deceased with no hospital transport.It was unknown whether that patient had any significant cardiac comorbidities that may have contributed to the mi, but it was stated the patient was morbidly obese with difficulty ambulating and they were tachycardic at baseline.It was confirmed the patient¿s mi, and subsequent death were 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 complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the cycler was returned to the manufacturer for physical evaluation.It was noted during a visual inspection of the returned cycler exterior that the power entry module was pushed inward and shattered.The ac input was separated from the toggle on/off switch section of the module.There were no visual indication of particulates within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The power entry module was replaced.After replacing the power entry module, the cycler powered up normally.A simulated treatment using (as-received) treatment settings with reduced dwell times was performed and completed without failures.No fluid leaks in the test cassette during the treatment test.The cycler performed and passed a system air leak test and a valve actuation test.The internal inspection of the cycler showed that there were visual indications of dried fluid on the bottom cover underneath the pump assembly.The cause of the encountered dried fluid could not be determined.A mushroom head check was performed and passed.There were no malfunctions found during testing 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 (b)(6) 2023, a peritoneal dialysis registered nurse ((pd)rn) reported to fresenius customer service this 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 at home on (b)(6) 2023 due to a myocardial infarction (mi).It was affirmed the patient was connected to his liberty select cycler at the time of the mi and subsequent death.The patient was found unresponsive by family at home and emergency services were activated but the patient was pronounced deceased with no hospital transport.It was unknown whether that patient had any significant cardiac comorbidities that may have contributed to the mi, but it was stated the patient was morbidly obese with difficulty ambulating and they were tachycardic at baseline.It was confirmed the patient¿s mi, and subsequent death were 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: 18283346
• MDR Text Key: 329947916
• Report Number: 0002937457-2023-01841
• Device Sequence Number: 1
• Product Code: FKX
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 02/08/2024
• 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: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 142 KG