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 Sepsis (2067); Peritonitis (2252); Malaise (2359)

Event Date 06/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.No further information related to the hospitalization, peritonitis, or death were available.

Manufacturer Narrative

Correction: b5.

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.It was confirmed that the patient passed away from complications of the infection.No further information related to the hospitalization, peritonitis, or death were available.

• 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: 15150299
• MDR Text Key: 297132743
• Report Number: 3008730267-2022-00108
• 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: 08/02/2022,08/17/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2022
• Distributor Facility Aware Date: 07/13/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 08/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/17/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female