MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95004
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	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The information in the complaint file has been reviewed.On (b)(6) 2022, during a follow up, a peritoneal dialysis registered nurse [(pd)rn] reported this patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler experienced peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient presented to the outpatient clinic on (b)(6) 2022 with abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the outpatient clinic on (b)(6) 2022 presented with staphylococcus epidermidis and a wbc count of 182/mm3.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.It was explained the patient has poor eyesight, so a caretaker typically assists the patient with pd therapy.The patient¿s caretaker was unavailable for a few pd treatments and the patient did not use his organizer which caused contamination to his extension set and patient line.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin every 5 days for two weeks and ip ceftazidime every day for two weeks (dosages unknown).The patient¿s ip ceftazidime was discontinued upon culture results.The patient recovered from this event and remains asymptomatic.It was confirmed the patient¿s peritonitis and associated symptoms were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home following this event.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• 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
• MDR Report Key: 15084765
• Report Number: 3008730267-2022-00097
• Device Sequence Number: 11736696
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2022
• Report Date (Section F): 07/22/2022

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 Model Number: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Date Report Sent to FDA: 07/22/2022