MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

A temporal relationship exists between the liberty select cycler, liberty cycler set and the reported adverse event(s) of fever, abdominal pain and subsequent diagnosis of peritonitis which required outpatient antibiotic therapy.The etiology of the event(s) of fever, abdominal pain and peritonitis cannot fully be appreciated at this time.However, the fever and abdominal pain were likely an early symptom of the underlying peritonitis.The product investigation, although unable to reproduce a malfunction, did note dried dialysate in the cassette housing.The product investigation regarding the liberty cycler set is still pending at the time of this clinical investigation.Due to a likely breach in sterility during ccpd therapy, a possible causal relationship cannot be ruled out.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

During a follow-up call on (b)(6) 2018 the peritoneal dialysis nurse (pdrn) reported the patient was training at the outpatient dialysis clinic, when the patient had to leave emergently for an appointment (details unknown).While the pdrn was breaking down the cycler, fluid (suspected dialysate) was noted in the cassette housing causing ¿everything to be wet.¿ the pdrn stated no alarms were encountered during pd therapy.A pd effluent fluid culture and cell count were collected on (b)(6) 2018 following the event(s).The culture results revealed no growth; however, the cell count showed an elevated white blood cell (wbc) count of 187.The patient was treated outpatient with intraperitoneal (ip) vancomycin 2g (frequency and duration unknown) and ip tobramycin 160mg (frequency and duration unknown).The pdrn reported the patient transitioned to in-center hemodialysis (hd) while the peritonitis was being treated and has since returned to home based ccpd therapy on (b)(6) 2018.

Manufacturer Narrative

The manufacturing plant received the alleged sample on 05/16/2018, code 050-87212, without its original package.During disinfection the alleged failure was confirmed, a leak was found on the cassette film.A visual inspection was performed to sample cassette and noticed a pin hole at the cassette film.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

".".

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 7547246
• MDR Text Key: 109516203
• Report Number: 8030665-2018-00784
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Device Catalogue Number: 050-87212
• Device Lot Number: 17PR08069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Device Age: MO
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARVEDILO; FERROUS SULFATE; FUROSEMIDE; HYDRALAZINE; LIBERTY SELECT; PD SOLUTION; SODIUM BICARBONATE; VITAMIN D3
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR