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

Catalog Number	050-87215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical review: 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A patient's contact reported that this patient on pd therapy has peritonitis.There were no reported allegations that the peritonitis was related to any issues with products.In additional follow-up, the pd nurse stated the patient was having symptoms of abdominal pain and cloudy pd effluent.As a result, on (b)(6) 2023, the patient was seen in the outpatient pd clinic.The patient had a pd culture obtained which grew candida tropicalis.The nurse stated the patient is being treated with antibiotic therapy using oral fluconazole (dose unknown) and intravenous vancomycin and ceftazidime (dose unknown) on an outpatient basis.Additionally, the patient was transitioned to back up hemodialysis for renal replacement needs and will undergo removal of the pd catheter (not a fresenius product).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.The nurse reported the patient is recovering from peritonitis event.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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
A patient's contact reported that this patient on pd therapy has peritonitis.There were no reported allegations that the peritonitis was related to any issues with products.In additional follow-up, the pd nurse stated the patient was having symptoms of abdominal pain and cloudy pd effluent.As a result, on (b)(6) 2023, the patient was seen in the outpatient pd clinic.The patient had a pd culture obtained which grew candida tropicalis.The nurse stated the patient is being treated with antibiotic therapy using oral fluconazole (dose unknown) and intravenous vancomycin and ceftazidime (dose unknown) on an outpatient basis.Additionally, the patient was transitioned to back up hemodialysis for renal replacement needs and will undergo removal of the pd catheter (not a fresenius product).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.The nurse reported the patient is recovering from peritonitis event.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• 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: 18234119
• Report Number: 0008030665-2023-01095
• Device Sequence Number: 11569587
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/14/2024
• 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 CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male