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

Catalog Number 050-87216

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Nausea (1970); Peritonitis (2252); Malaise (2359)

Event Date 01/03/2024

Event Type  Injury  

Event Description

On 9/jan/2024, fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized and was diagnosed with peritonitis.The patient reported his pd catheter (not a fresenius product) was surgically removed, and he transitioned to incenter hemodialysis (hd).No additional information was provided during intake.In the days leading up to the patient¿s hospitalization, clinical progress notes indicated the patient was complaining of shortness of breath (dyspnea) since 8/dec/2023.The patient reported concerns his dyspnea was likely an indicator his atrial fibrillation (a-fib) had returned, and his pd registered nurse (pdrn) recommended he go to the hospital.The patient was not hospitalized, and additional clinical progress notes revealed the patient was consistently non-compliant (i.E., mircera dosing, performing treatment, clinic appointments/recommendations).Additionally, the patient refused to be assessed at the outpatient home dialysis clinic on multiple occasions, despite experiencing continued dyspnea, as well as weakness and malaise.On (b)(6) 2024, the patient presented to the emergency room (er) after no ccpd therapy in 48 hours (rationale not provided), with worsening abdominal pain (3-weeks, sharp, pain scale = 9/10), diarrhea (upwards of seven stools per day), nausea, and fever.The patient¿s admission vitals included: blood pressure = 102/65, heart rate = 110 bpm, respiration rate = 16 min, temperature = 37.8 ¿ 38.2, oxygen saturation = 100% (baseline 3-liter oxygen requirement).A computed tomography (ct) scan of the patient¿s abdomen revealed possible gastritis, colonic wall thickening, fluid in the sigmoid colon, and stranding edema with mild free fluid in the abdomen or pelvis.The patient was formally admitted and diagnosed with peritonitis and clostridium difficile.The patient was treated with oral vancomycin, intravenous (iv) cefepime, and iv flagyl (doses, frequency, duration not provided).On (b)(6) 2024, the patient underwent the surgical placement of a hemodialysis (hd) catheter (not a fresenius product) and was transitioned to hd for rrt the same day.The hpm reported the patient transitioned to hd because he no longer wanted to perform pd therapy at home.The remainder of the patient¿s hospitalization was unremarkable; however, it should be noted the patient¿s hemoglobin dropped to 5.9 g/l (cause not provided) and he was transfused with 2 units of packed red blood cells (hemoglobin increased to 8.3 g/l).The patient was discharged on (b)(6) 2024 in stable condition and will begin incenter hd on 11/jan/2024.Upon discharge, the patient¿s antibiotic regimen was changed to iv vancomycin 500 mg post hd 3 times-a-week, iv ceftazidime 1000 mg post hd 3 times-a-week, and oral flagyl 500 mg twice daily until 24/jan/2024 due to culture negative pd catheter (not a fresenius product) associated peritonitis.Additionally, the patient¿s oral vancomycin continued for 10 days due to the clostridium difficile infection.Per the documentation provided, the patient has recovered from the serious adverse events.

• 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: 18512468
• MDR Text Key: 332889226
• Report Number: 3023981687-2024-00016
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 01/15/2024
• Distributor Facility Aware Date: 01/09/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/15/2024
• Date Manufacturer Received: 01/09/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 54 KG