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	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a patient on peritoneal dialysis (pd) was hospitalized with peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.The event was reported when placing the patient on hold for pd therapy as the patient is expected to have the pd catheter (not a fresenius product) removed and transition to hemodialysis.In additional follow-up, the patient¿s pd nurse stated the patient was having symptoms of abdominal pain.On (b)(6) 2024, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture grew escherichia coli and klebsiella.The patient was initiated on meropenem 1 gram and vancomycin 1 gram intra-peritoneal (ip) on an outpatient basis.However, subsequently on (b)(6) 2024, the patient was admitted into the hospital for persistent symptoms of abdominal despite antibiotic therapy.The nurse confirmed that the patient is expected to have the pd catheter removed with transition to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed and is expected to undergo pd catheter repair.No further information about the hospitalization is available.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 any malfunctions with fresenius products in relation to this event.
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 nurse reported a patient on peritoneal dialysis (pd) was hospitalized with peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.The event was reported when placing the patient on hold for pd therapy as the patient is expected to have the pd catheter (not a fresenius product) removed and transition to hemodialysis.In additional follow-up, the patient¿s pd nurse stated the patient was having symptoms of abdominal pain.On (b)(6) 2024, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture grew escherichia coli and klebsiella.The patient was initiated on meropenem 1 gram and vancomycin 1 gram intra-peritoneal (ip) on an outpatient basis.However, subsequently on (b)(6) 2024, the patient was admitted into the hospital for persistent symptoms of abdominal despite antibiotic therapy.The nurse confirmed that the patient is expected to have the pd catheter removed with transition to hemodialysis for renal replacement needs.The patient remained in the hospital at the time follow-up was performed and is expected to undergo pd catheter repair.No further information about the hospitalization is available.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 any malfunctions 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.

• 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: 20561290
• Report Number: 0008030665-2024-00974
• Device Sequence Number: 14259012
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 11/15/2024

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female