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); Peritoneal effluent abnormal (4904)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis, due to failing to place a staysafe end cap on the pd catheter (not a fresenius product) at the termination of treatment.Follow-up with the patients¿ pd registered nurse (pdrn) 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 (wbc = 719 u/l, neutrophils = 62%) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and ceftazidime for 14 days.The patient¿s peritoneal effluent culture result returned negative for growth; however, the patient¿s vancomycin and ceftazidime were continued.The patient continued to undergo ccpd while hospitalized and was discharged in stable condition on (b)(6)2025.The patient is recovering from the serious adverse events, and resumed utilizing the same liberty select cycler at home without reported issues.The pdrn attributed causality to a breach in sterility, as the patient failed to place a staysafe end cap on her pd catheter (not a fresenius product) at the end of treatment.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical review: a temporal relationship exists between ccpd therapy utilizing a sterile stay safe cap and the serious adverse events of peritonitis (characterized by abdominal pain and cloudy peritoneal effluent fluid), which required hospitalization and ip antibiotic therapy.The pdrn attributed causality to the patient forgetting to apply a stay safe end cap to the pd catheter (not a fresenius product) at the termination of treatment.In approximately 20% of all peritonitis cases, no organism is identified.Instead, physiological factors (i.E., elevated cell count, abdominal pain) are used to identify the infection.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Per the pdrn, the serious adverse events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Based on the information available, the patient¿s liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.
Event or Problem Description
It was reported that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis, due to failing to place a staysafe end cap on the pd catheter (not a fresenius product) at the termination of treatment.Follow-up with the patients¿ pd registered nurse (pdrn) 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 (wbc = 719 u/l, neutrophils = 62%) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and ceftazidime for 14 days.The patient¿s peritoneal effluent culture result returned negative for growth; however, the patient¿s vancomycin and ceftazidime were continued.The patient continued to undergo ccpd while hospitalized and was discharged in stable condition on (b)(6) 2025.The patient is recovering from the serious adverse events, and resumed utilizing the same liberty select cycler at home without reported issues.The pdrn attributed causality to a breach in sterility, as the patient failed to place a staysafe end cap on her pd catheter (not a fresenius product) at the end of treatment.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.
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 sterile stay safe cap 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.There is no allegation of a 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 malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.
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 the product involved 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.There is no allegation of 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 malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.
Event or Problem Description
It was reported that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis, due to failing to place a staysafe end cap on the pd catheter (not a fresenius product) at the termination of treatment.Follow-up with the patients¿ pd registered nurse (pdrn) 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 (wbc = 719 u/l, neutrophils = 62%) were collected, and the patient was formally admitted.The patient was diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin and ceftazidime for 14 days.The patient¿s peritoneal effluent culture result returned negative for growth; however, the patient¿s vancomycin and ceftazidime were continued.The patient continued to undergo ccpd while hospitalized and was discharged in stable condition on (b)(6) 2025.The patient is recovering from the serious adverse events and resumed utilizing the same liberty select cycler at home without reported issues.The pdrn attributed causality to a breach in sterility, as the patient failed to place a staysafe end cap on her pd catheter (not a fresenius product) at the end of treatment.Per the pdrn, the events were not caused by any fresenius product(s) and/or device(s) deficiency or malfunction.

• 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: 21927692
• Report Number: 0008030665-2025-00974
• Device Sequence Number: 18397513
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/17/2025

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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 06/16/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/12/2025; 06/17/2025
• 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: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female