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

Model Number LIBERTY CYCLER SET, SINGLE PATIENT CONN

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

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Peritoneal dialysis nurse reported that during peritoneal dialysis treatment with a liberty cycler, the cassette ¿exploded¿ during the second drain.Follow up with the peritoneal dialysis nurse indicates that the patient was at the clinic and was being trained on use with the cycler.It is unknown if the cycler alarmed when the leak was encountered.The patient reportedly developed abdominal pain and vomiting.The patient was prescribed prophylactic antibiotics.The patient was not culture.Patient¿s effluent was reportedly clear.The patient has resumed treatment with no further complications.

Manufacturer Narrative

The manufacturing plant received on (b)(6) 2018 a actual sample of code (b)(4) 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 actual sample 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

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Manufacturer Narrative

Correction: catalogue number.A supplemental report will be submitted upon completion of the plant¿s investigation.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• 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: 7554127
• MDR Text Key: 109631902
• Report Number: 8030665-2018-00808
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• 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,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Device Catalogue Number: 050-87216
• Device Lot Number: 17SR08034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Device Age: MO
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER; PD SOLUTION