MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	06/22/2024
Type of Reportable Event	Serious Injury
Additional 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 the pd therapy with the liberty select cycler/ liberty cycler set and the patient¿s peritonitis event.Based on the reported information, the cause of the patient¿s peritonitis cannot be determined at this time.However, currently there is no allegation nor any objective evidence that a liberty cycler set malfunction or product deficiency was associated with this event.Peritonitis is a well-documented complication in patients undergoing pd therapy most often associated with a breach in aseptic technique during the pd exchange.
Event or Problem Description
On 1/jul/2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse confirmed the patient was admitted to the hospital on (b)(6) 2024 for peritonitis.However, the nurse was not able to provide any details about the hospitalization, including pd culture results and treatment information.The nurse stated the patient is being transitioned to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.The patient¿s nurse was not able to identify the exact cause of the patient¿s peritonitis is unknown.However, the nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to this event.
Event or Problem Description
On (b)(6) 2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse confirmed the patient was admitted to the hospital on (b)(6) 2024 for peritonitis.However, the nurse was not able to provide any details about the hospitalization, including pd culture results and treatment information.The nurse stated the patient is being transitioned to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.The patient¿s nurse was not able to identify the exact cause of the patient¿s peritonitis is unknown.However, the nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to this event.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
On (b)(6) 2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse confirmed the patient was admitted to the hospital on (b)(6) 2024 for peritonitis.However, the nurse was not able to provide any details about the hospitalization, including pd culture results and treatment information.The nurse stated the patient is being transitioned to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed.The patient¿s nurse was not able to identify the exact cause of the patient¿s peritonitis is unknown.However, the nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to this event.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19748158
• Report Number: 0008030665-2024-00621
• Device Sequence Number: 17786849
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: Lay User/Patient
• Device Catalogue Number: 050-87215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 07/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/22/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION; PD SOLUTION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male