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); Peritonitis (2252)

Event Date 03/07/2024

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported to a pd patient on continuous cyclic pd (ccpd) therapy experienced peritonitis and was hospitalized.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with staphylococcus epidermidis in the culture and a wbc count of 2644/mm3.The patient was diagnosed with peritonitis due to unknown etiology.Based on the culture results, the cause of this infection was more than likely touch contamination during pd therapy; however, the outpatient clinic could not confirm the exact source at the time of follow up.The patient was prescribed intraperitoneal (ip) vancomycin and ip cefepime (dosages, frequency and durations unknown) to address this infection.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient is recovering from this event while awaiting discharge to home.It was confirmed, though the exact cause of this patient¿s adverse event remains unknown, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home post-discharge.

Manufacturer Narrative

Correction: the date provided for f.6.In the initial importer emdr should have been 3-11-2024.

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported to a pd patient on continuous cyclic pd (ccpd) therapy experienced peritonitis and was hospitalized.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2024.Following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with staphylococcus epidermidis in the culture and a wbc count of 2644/mm3.The patient was diagnosed with peritonitis due to unknown etiology.Based on the culture results, the cause of this infection was more than likely touch contamination during pd therapy; however, the outpatient clinic could not confirm the exact source at the time of follow up.The patient was prescribed intraperitoneal (ip) vancomycin and ip cefepime (dosages, frequency and durations unknown) to address this infection.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient is recovering from this event while awaiting discharge to home.It was confirmed, though the exact cause of this patient¿s adverse event remains unknown, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home post-discharge.

• 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: 18966156
• MDR Text Key: 338433944
• Report Number: 3023981687-2024-00082
• 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: 04/04/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2024
• Distributor Facility Aware Date: 04/04/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 04/04/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 40 KG