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 Chest Pain (1776)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: based on the required 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.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.

Event Description

On (b)(4) 2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius technical services they experienced severe chest pain and needed to discontinue a ccpd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient experienced chest pain on 6/feb/2024 during a ccpd treatment on the liberty select cycler at home.The patient was safely disconnected from their cycler by emergency services and transported to the hospital via ambulance.The patient was admitted to the hospital on the same day for observation as they did not receive a diagnosis involving their chest pain or require medical intervention.It was believed the patient did manual exchanges for renal replacement therapy during their hospital stay.The patient had an uneventful hospital course and was discharged to home on 7/feb/2024.It was affirmed the patient did not have any cardiac issues that led to their chest pain, nor did they have any serious injury or adverse event in relation to fresenius cycler or product use.Additionally, it was confirmed the patient¿s chest pain, and the associated hospitalization were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and continues ccpd therapy on the same liberty select cycler at home.

Event Description

On (b)(6) 2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius technical services they experienced severe chest pain and needed to discontinue a ccpd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient experienced chest pain on 6/feb/2024 during a ccpd treatment on the liberty select cycler at home.The patient was safely disconnected from their cycler by emergency services and transported to the hospital via ambulance.The patient was admitted to the hospital on the same day for observation as they did not receive a diagnosis involving their chest pain or require medical intervention.It was believed the patient did manual exchanges for renal replacement therapy during their hospital stay.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was affirmed the patient did not have any cardiac issues that led to their chest pain, nor did they have any serious injury or adverse event in relation to fresenius cycler or product use.Additionally, it was confirmed the patient¿s chest pain, and the associated hospitalization were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and continues ccpd therapy on the same liberty select cycler at home.

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.

• 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: 18856787
• MDR Text Key: 337116720
• Report Number: 0002937457-2024-00401
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Hospitalization
• Patient Sex: Female