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

Model Number	050-95001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Peritonitis (2252); Lethargy (2560)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient reported a fluid leak during pd treatment.There was an air detected in cassette warning during drain 3 of 5.The patient found a fluid leak in the patient line and attempted to tape the tube and proceeded with treatment.Patient then got a watchdog timer error.Tech services assisted patient in a re-setup and re-started patient at fill 4 of 6.In a follow up with pd nurse at the facility it was reported that the patient was in the hospital with peritonitis.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2022 for ventricular tachycardia due to preexisting cardiac disease.The patient also presented with a fever, lethargy, abdominal pain and cloudy peritoneal effluent fluid determined to be unrelated to the patient¿s ventricular tachycardia.Peritoneal effluent fluid cultures and a white blood cell (wbc) count were obtained in the hospital (exact date unknown); however, laboratory results were not reported to the outpatient clinic.The outpatient clinic¿s physician was advised the infectious pathogen that caused the patient¿s peritonitis involved a bacterium found only in cats.The genus and species of this bacterium was not reported.It was explained the patient experienced a fluid leak from his extension set during a pd treatment on (b)(6) 2022 and the leak was initially thought to be the cause; however, upon effluent fluid culture results and the patient¿s admission that he keeps his cats in the room during nightly pd therapy, the root cause of this reported event could not be determined.The patient was prescribed antibiotics during this admission, but the type, route, dose, frequency and duration were not reported to the outpatient clinic.The patient has been able to undergo pd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient remains admitted for cardiac issues while receiving treatment for this infection.Though the root cause of this event could not be determined due to multiple potential sources, it was believed if the infection involved the leak in the patient¿s extension set, it was the act of applying tape to the tubing to stop the leak that was the most likely cause of the peritonitis.The patient plans to continue pd therapy on the same liberty select cycler at home upon discharge.

• Brand Name: STAY SAFE/SAFE 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: 15844314
• Report Number: 3008730267-2022-00206
• Device Sequence Number: 12511466
• Product Code: KDJ
• UDI-Device Identifier: 00840861100767
• UDI-Public: 00840861100767
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022
• Report Date (Section F): 11/22/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95001
• Device Catalogue Number: 050-95001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 11/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Date Report Sent to FDA: 11/22/2022