MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STERILE STAY SAFE CAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95012
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	01/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13/jan/2025, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler, liberty cycler set and stay safe cap for renal replacement therapy (rrt) contracted peritonitis, and his pd catheter (not a fresenius product) was removed.No additional information was provided during the intake process.Follow-up with the patient¿s pd registered nurse [(pd)rn] confirmed the patient presented to the emergency room on (b)(6) 2025 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results unavailable) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and treated with intraperitoneal (ip) vancomycin 2000 mg every three days and ceftazidime 1500 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for methicillin resistant staphylococcus aureus (mrsa) on (b)(6) 2025, and the patient¿s antibiotics were continued.Upon receiving the peritoneal effluent fluid culture results, the nephrologist ordered the removal of the patient¿s pd catheter on (b)(6) 2025 and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed the same day.The patient transitioned to hd for rrt without any reported issues and will complete the remaining antibiotic course intravenously.The patient was discharged home on (b)(6) 2024 in stable condition and began outpatient hd therapy on (b)(6) 2025.The pdrn attributed causality to the patient¿s reuse of a stay safe end cap.The patient reportedly completed treatment and realized he did not have a replacement cap and reused the pretreatment stay safe end cap.Reeducation was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo hd on an outpatient basis without any known issues.
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 ccpd therapy utilizing the stay safe cap, and the serious adverse events of peritonitis, characterized by abdominal pain and cloudy effluent fluid, which required hospitalization, antibiotic therapy, removal of the patient¿s pd catheter (not a fresenius product) and transition to hd for rrt.The pdrn attributed causality to the patient¿s reuse of a stay safe end cap.The patient reportedly completed treatment and reused the pretreatment stay safe end cap.Staphylococcus aureus is commonly found in the mucus membranes and skin of humans and is the most frequent organism associated with peritoneal infections in pd patients.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo hd on an outpatient basis without any known issues.Based on the information available, the stay safe cap can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product failed to meet the users¿ expectations or the manufacturers¿ specifications.
Additional Manufacturer Narrative
Plant investigation: no parts or samples were returned to the manufacturer which prevented the completion of a physical evaluation.Additionally, a lot number was not included among the information provided by the customer which prevented the review of any retained samples.The manufacturer confirmed that the batch release occurs when all products have been inspected according to protocol and found to be conforming to specification.Based on the provide information, the manufacturer determined the cause for the reported issue to be a user-related issue since the patient reused the pretreatment stay safe end cap.
Event or Problem Description
On (b)(6) 2025, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler, liberty cycler set and stay safe cap for renal replacement therapy (rrt) contracted peritonitis, and his pd catheter (not a fresenius product) was removed.No additional information was provided during the intake process.Follow-up with the patient¿s pd registered nurse [(pd)rn] confirmed the patient presented to the emergency room on (b)(6) 2025 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results unavailable) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and treated with intraperitoneal (ip) vancomycin 2000 mg every three days and ceftazidime 1500 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for methicillin resistant staphylococcus aureus (mrsa) on (b)(6) 2025, and the patient¿s antibiotics were continued.Upon receiving the peritoneal effluent fluid culture results, the nephrologist ordered the removal of the patient¿s pd catheter on (b)(6) 2025 and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed the same day.The patient transitioned to hd for rrt without any reported issues and will complete the remaining antibiotic course intravenously.The patient was discharged home on (b)(6) 2024 in stable condition and began outpatient hd therapy on (b)(6) 2025.The pdrn attributed causality to the patient¿s reuse of a stay safe end cap.The patient reportedly completed treatment and realized he did not have a replacement cap and reused the pretreatment stay safe end cap.Reeducation was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo hd on an outpatient basis without any known issues.
Additional Manufacturer Narrative
Correction: h10 plant investigation plant investigation: the plant did not receive the complaint product sample physically for evaluation, neither photos or videos were provided from the customer.Should the sample become available, the investigation file will be reopened and will be updated accordingly.Since the lot number of product involved is unknown a shipping search on the system was performed of the lots delivered to the patient within three months prior to the event date.At this time a search in the system was performed to verify product availability for alternate samples at the distribution centers.According to the system no product is available of the lots delivered to the patient, on distribution centers to be analyzed.There is no allegation of cassette malfunction based in the complaint description and information provided the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.
Event or Problem Description
On 13/jan/2025, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler, liberty cycler set and stay safe cap for renal replacement therapy (rrt) contracted peritonitis, and his pd catheter (not a fresenius product) was removed.No additional information was provided during the intake process.Follow-up with the patient¿s pd registered nurse [(pd)rn] confirmed the patient presented to the emergency room on (b)(6)2025 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results unavailable) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and treated with intraperitoneal (ip) vancomycin 2000 mg every three days and ceftazidime 1500 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for methicillin resistant staphylococcus aureus (mrsa) on (b)(6)2025, and the patient¿s antibiotics were continued.Upon receiving the peritoneal effluent fluid culture results, the nephrologist ordered the removal of the patient¿s pd catheter on (b)(6)2025 and a temporary hemodialysis (hd) catheter (not a fresenius product) was surgically placed the same day.The patient transitioned to hd for rrt without any reported issues and will complete the remaining antibiotic course intravenously.The patient was discharged home on (b)(6)2024 in stable condition and began outpatient hd therapy on (b)(6)2025.The pdrn attributed causality to the patient¿s reuse of a stay safe end cap.The patient reportedly completed treatment and realized he did not have a replacement cap and reused the pretreatment stay safe end cap.Reeducation was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient continues to undergo hd on an outpatient basis without any known issues.

• Brand Name: STERILE STAY SAFE CAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• 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: 21169589
• Report Number: 0008030665-2025-00120
• Device Sequence Number: 4336461
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083542
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 050-95012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/08/2025; 03/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/10/2025; 03/06/2025
• 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 CYCLER SET; 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: 43 YR
• Patient Sex: Male
• Patient Weight: 93 KG