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 Nausea (1970); Urinary Tract Infection (2120); Peritonitis (2252)

Event Date 04/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023 the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.

Event Description

On (b)(6) 2023, this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023, the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.

• 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: 16901887
• MDR Text Key: 314898847
• Report Number: 3023981687-2023-00096
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023,05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2023
• Distributor Facility Aware Date: 04/19/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 05/10/2023
• Date Manufacturer Received: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEFLEX PD FLUID; DEFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female