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 Material Puncture/Hole (1504)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that this patient on peritoneal dialysis (pd) had a cassette with a hole and the patient developed peritonitis.The patient was seen in the outpatient pd clinic for symptoms of abdominal pain and cloudy pd effluent.It was stated that the patient had a pd culture obtained which grew the bacteria streptococcus sanguinis.The patient was treated with intra-peritoneal (ip) antibiotics with vancomycin and ceftazidime (per clinic protocol) on an outpatient basis.The patient is recovering from the event.Per the nurse, the patient continues pd therapy with the same cycler and a new batch of fresenius cassettes (lot number unknown) without any further issues.The nurse attributed the peritonitis to the fluid leak from the hole in the fresenius cassette.

• 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: 18983918
• MDR Text Key: 338661187
• Report Number: 3023981687-2024-00084
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Device Lot Number: 23KR08052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2024
• Distributor Facility Aware Date: 03/13/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/26/2024
• Date Manufacturer Received: 03/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Age: 73 YR
• Patient Sex: Female