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

Model Number	180111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	07/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 cycler and the adverse event of a seizure.In the absence of a confirmed source from a medical professional, the root cause of the patient¿s seizure remains unknown.Seizure activity is a known occurrence for the esrd population in the form of an acute episodic seizure and/or patients who develop chronic kidney disease through the course of preexisting epilepsy (1).Due to the limited information obtained for this patient¿s seizure during a pd treatment, the liberty cycler cannot be excluded as a potential source or contributor to this adverse event.Based on the available 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 event.
Event or Problem Description
It was reported a peritoneal dialysis (pd) patient was taken to the emergency room after experiencing a seizure during treatment.The liberty cycler utilized for the treatment was registered to a fresenius acute facility, however, details on the health care provider, patient, and location of the event were not reported.It is unknown if the patient owns fresenius pd products.There was no allegation that the hospitalization was related to the use of a fresenius device, drug, or product.Multiple attempts were made to acquire additional information, however, a response was not received.
Additional 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 or Problem Description
It was reported a peritoneal dialysis (pd) patient was taken to the emergency room after experiencing a seizure during treatment.The liberty cycler utilized for the treatment was registered to a fresenius acute facility, however, details on the health care provider, patient, and location of the event were not reported.It is unknown if the patient owns fresenius pd products.There was no allegation that the hospitalization was related to the use of a fresenius device, drug, or product.Multiple attempts were made to acquire additional information, however, a response was not received.
Additional Manufacturer Narrative
Corrections: g1 additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer.No physical damage was noted during an external visual inspection.There was dried fluid within the cassette compartment.There were no particulates within the cassette area.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.The cycler underwent and passed a system air leak test and valve actuation test.A mushroom head check passed.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.There were no other visual discrepancies observed during the internal inspection.A review of the device manufacturing records was conducted and 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 was no problem detected.
Event or Problem Description
It was reported a peritoneal dialysis (pd) patient was taken to the emergency room after experiencing a seizure during treatment.The liberty cycler utilized for the treatment was registered to a fresenius acute facility, however, details on the health care provider, patient, and location of the event were not reported.It is unknown if the patient owns fresenius pd products.There was no allegation that the hospitalization was related to the use of a fresenius device, drug, or product.Multiple attempts were made to acquire additional information, however, a response was not received.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Common Device Name: 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: 12341598
• Report Number: 2937457-2021-01731
• Device Sequence Number: 4418481
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 02/07/2023
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/15/2021; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown