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	11/18/2024
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 review: a temporal relationship exists between ccpd therapy requiring the aseptic removal and replacement of the patient's stay-safe catheter cap and the adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid.It is well established that pd patients are at high risk for infections of the peritoneum.The root cause of this patient¿s peritonitis can be attributed to a break in asepsis by not protecting the access of his pd catheter involving not replacing the stay-safe catheter cap following therapy as reported by a medical professional.Nonadherence to asepsis during pd therapy, or otherwise, is the leading source of transmission of peritonitis causing pathogens.This is further evidenced by the presence of a gram-negative microorganism that is typically associated with human enteric flora.Therefore, the stay-safe catheter cap can be excluded as a potential source or contributor to this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.
Additional Manufacturer Narrative
Correction provided in d4.Investigation: a batch number was not documented.As the complaint sample was not returned it was not assessed if the product deficiency is related to falsification.The complaint sample was not investigated.Due to various 100% inspections during manufacturing, it is highly unlikely to detect a failure in the retained samples.Batch record investigation (dhr): based on the missing information about the affected batch the batch record could not be checked.A failure at the disinfection cap could not be detected.A risk assessment was not performed as the event was explained as ¿the patient was found not to have the stay-safe cap on his catheter on multiple occasions¿ (known risk of user error).User related circumstances/user related handling issue (use error) was most probably the reason for the complaint.
Event or Problem Description
It was reported during follow up that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced peritonitis.There was no specific allegation these adverse events were due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow-up with this patient¿s pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the outpatient clinic on (b)(6) 2024 presented with gram-negative bacilli (organism not reported) in the culture and a wbc count of 1700/mm3.The patient was diagnosed with peritonitis due to a break in asepsis to his pd catheter (not a fresenius product).It was explained the patient was found not to have the stay-safe cap on his catheter on multiple occasions prior to this infection.There was no indication of an issue with the patient¿s catheter stay-safe cap, rather it was determined the cap was not appropriately replaced by the patient following therapy.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 2000 mg daily for two weeks.The patient recovered from this event at home on antibiotic therapy.It was confirmed the patient¿s peritonitis was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on a newly received liberty select cycler at home.
Event or Problem Description
It was reported during follow up that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced peritonitis.There was no specific allegation these adverse events were due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow-up with this patient¿s pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the outpatient clinic on (b)(6) 2024 presented with gram-negative bacilli (organism not reported) in the culture and a wbc count of 1700/mm3.The patient was diagnosed with peritonitis due to a break in asepsis to his pd catheter (not a fresenius product).It was explained the patient was found not to have the stay-safe cap on his catheter on multiple occasions prior to this infection.There was no indication of an issue with the patient¿s catheter stay-safe cap, rather it was determined the cap was not appropriately replaced by the patient following therapy.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 2000 mg daily for two weeks.The patient recovered from this event at home on antibiotic therapy.It was confirmed the patient¿s peritonitis was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on a newly received liberty select cycler at home.
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 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 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 malfunction.As there is no allegation related to product manufacture, the complaint is deemed unconfirmed.
Event or Problem Description
It was reported during follow up that this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced peritonitis.There was no specific allegation these adverse events were due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow-up with this patient¿s pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid noted at home.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the outpatient clinic on (b)(6) 2024 presented with gram-negative bacilli (organism not reported) in the culture and a wbc count of 1700/mm3.The patient was diagnosed with peritonitis due to a break in asepsis to his pd catheter (not a fresenius product).It was explained the patient was found not to have the stay-safe cap on his catheter on multiple occasions prior to this infection.There was no indication of an issue with the patient¿s catheter stay-safe cap, rather it was determined the cap was not appropriately replaced by the patient following therapy.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 2000 mg daily for two weeks.The patient recovered from this event at home on antibiotic therapy.It was confirmed the patient¿s peritonitis was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on a newly received liberty select cycler at home.

• 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: 21103414
• Report Number: 0008030665-2025-00057
• Device Sequence Number: 8629242
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/07/2025

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/20/2025; 02/07/2025
• 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 SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG