MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Malaise (2359)

Event Date 05/02/2022

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported this pd patient was suspected of contracting peritonitis and experienced drain complications during pd therapy.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 generally ill with abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2022 (the patient returned the following day with effluent sample) presented with staphylococcus aureus and a white blood cell (wbc) count of 7988/mm3.The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.It was explained due to the patient¿s advanced age, his daughter assists with pd treatments, and she does not always take aseptic precautions.The patient was not hospitalized for this event and initially prescribed intraperitoneal (ip) vancomycin at 1500 mg every three days for two weeks and ip gentamycin at 100 mg every day for two weeks.The ip gentamycin was discontinued upon culture results.The patient is recovering from this event while remaining asymptomatic.Additionally, the patient¿s drain complications have resolved with the treatment of the peritonitis infection.It was confirmed the patient¿s peritonitis and the associated drain complications 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: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 14397878
• MDR Text Key: 291638338
• Report Number: 3008730267-2022-00029
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Distributor Facility Aware Date: 05/05/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 05/13/2022
• Date Manufacturer Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 98 YR
• Patient Sex: Male
• Patient Weight: 83 KG