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); Abdominal Cramps (2543)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, abdominal cramping and cloudy effluent fluid, which required hospitalization and antibiotic therapy.The pdrn attributed causality to a poorly tightened stay safe cap which became dislodged and leaked fluid.The patient wrapped the pd catheter (not a fresenius product) with non-occlusive paper tape which was saturated upon his arrival to the er.Klebsiella oxytoca and enterobacter cloacae are most frequently found in the gastrointestinal tract and in human stool.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.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.
Event or Problem Description
It was reported to fresenius customer service that a peritoneal dialysis (pd) patient was hospitalized due to peritonitis.No additional information was provided during the initial reporting.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room (er) on (b)(6)2024 with complaints of abdominal pain, abdominal cramping, and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 9,278 u/l, polymorph cells = 97%) were collected, and the patient was diagnosed with peritonitis.The patient was admitted and treated with intraperitoneal (ip) ceftriaxone 1000 mg daily, oral levofloxacin 250 mg every 48 hours, and oral fluconazole 100 mg daily for 18 days.The patient¿s preliminary peritoneal effluent culture result returned positive for klebsiella oxytoca and enterobacter cloacae on (b)(6)2024, and the patient¿s antibiotics were continued.The pdrn attributed causality to a poorly tightened end cap which became dislodged and leaked fluid.The patient wrapped the pd catheter (not a fresenius product) with non-occlusive paper tape which was saturated upon their arrival to the er.The patient was discharged on (b)(6)2024 in stable condition and is recovering from the serious adverse events.The patient reportedly continued to undergo continuous cyclic pd (ccpd) therapy while hospitalized, and resumed ccpd at home following discharge utilizing the same liberty select cycler.Per the pdrn, the serious adverse 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 all sterile stay safe caps 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
It was reported to fresenius customer service that a peritoneal dialysis (pd) patient was hospitalized due to peritonitis.No additional information was provided during the initial reporting.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the emergency room (er) on (b)(6) 2024 with complaints of abdominal pain, abdominal cramping, and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 9,278 u/l, polymorph cells = 97%) were collected, and the patient was diagnosed with peritonitis.The patient was admitted and treated with intraperitoneal (ip) ceftriaxone 1000 mg daily, oral levofloxacin 250 mg every 48 hours, and oral fluconazole 100 mg daily for 18 days.The patient¿s preliminary peritoneal effluent culture result returned positive for klebsiella oxytoca and enterobacter cloacae on (b)(6) 2024, and the patient¿s antibiotics were continued.The pdrn attributed causality to a poorly tightened end cap which became dislodged and leaked fluid.The patient wrapped the pd catheter (not a fresenius product) with non-occlusive paper tape which was saturated upon their arrival to the er.The patient was discharged on (b)(6) 2024 in stable condition and is recovering from the serious adverse events.The patient reportedly continued to undergo continuous cyclic pd (ccpd) therapy while hospitalized, and resumed ccpd at home following discharge utilizing the same liberty select cycler.Per the pdrn, the serious adverse 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: 21175417
• Report Number: 0008030665-2025-00148
• Device Sequence Number: 8537445
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/13/2025

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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/13/2025
• 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; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 68 KG