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	050-87216A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Peritonitis (2252); Unspecified Gastrointestinal Problem (4491)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this peritoneal dialysis (pd) patient had an infection at the pd catheter (not an fme product).The catheter was removed and the patient transitioned to in-center hemodialysis (hd).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6) 2026 due to weakness and gastrointestinal (gi) upset.The patient was admitted.The patient had pd cultures obtained on (b)(6) 2026.The patient was diagnosed with peritonitis on (b)(6) 2026 when the pd culture returned positive for corynebacterium jeikeium.The white blood cell (wbc) count was 2,389.During the hospitalization, the patient was administered intravenous (iv) zosyn, vancomycin, ancef, and zyvox (dose, frequency, and duration unknown).The pd catheter was removed (date not provided).The patient was permanently transitioned to hemodialysis (hd).The cause of the peritonitis is unknown.The patient did have a recent hospitalization on (b)(6) 2026-(b)(6) 2026 due to gastroenteritis which was unrelated to pd therapy or the use of any fresenius medical care products.
Event or Problem Description
It was reported that this peritoneal dialysis (pd) patient had an infection at the pd catheter (not an fme product).The catheter was removed and the patient transitioned to in-center hemodialysis (hd).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6)2026 due to weakness and gastrointestinal (gi) upset.The patient was admitted.The patient had pd cultures obtained on (b)(6)/2026.The patient was diagnosed with peritonitis on (b)(6)2026 when the pd culture returned positive for corynebacterium jeikeium.The white blood cell (wbc) count was 2,389.During the hospitalization, the patient was administered intravenous (iv) zosyn, vancomycin, ancef, and zyvox (dose, frequency, and duration unknown).The pd catheter was removed (date not provided).The patient was permanently transitioned to hemodialysis (hd).The cause of the peritonitis is unknown.The patient did have a recent hospitalization on (b)(6)2026-(b)(6)2026 due to gastroenteritis which was unrelated to pd therapy or the use of any fresenius medical care products.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between peritoneal dialysis, and the utilization of the liberty select cycler and the liberty cycler set and the patient event of peritonitis with hospitalization and subsequent transition to hemodialysis.However, there is no documentation showing a causal relationship between the adverse event and use of the liberty select cycler and the liberty cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.Although the cause of the peritonitis event was not determined, corynebacterium jeikeium is known to be related to nosocomial (hospital-acquired) infections such as peritonitis.This patient did have a recent hospitalization prior to this peritonitis event.C.Jeikeium is part of the human skin flora and therefore a breach in aseptic technique could have occurred at that time.Based on the available information and no allegation or evidence of a malfunction, deficiency, or defect, the liberty select cycler and liberty cycler set can be excluded as the cause of the patient¿s 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 medical care (fme) 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.

• 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 ; +1(617)417-5172
• MDR Report Key: 50674122
• Report Number: 0008030665-2026-02411
• Device Sequence Number: 14772134
• Product Code: FKX
• UDI-Device Identifier: 00840861102716
• UDI-Public: 00840861102716
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 050-87216A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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: Delflex PD Fluid; Delflex PD Fluid; Liberty Select Cycler; Liberty Select Cycler
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 121 LB