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 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Peritoneal dialysis patient reported to technical support during troubleshooting of a cycler alarm that a fluid leak was observed.The patient cancelled the treatment and was advised to contact the clinic nurse.Follow up with the peritoneal dialysis nurse indicates that the patient did not complete treatment after the alleged event occurred.There was no medical intervention.The patient did not experience any complications as a result of the alleged event.Additional information was solicited.

Event Description

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Manufacturer Narrative

Manufacturing plant received on 05/18/2018 the actual sample one cassette from code 050-87216 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 pin holes at the cassette film.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• 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: 7528633
• MDR Text Key: 108733345
• Report Number: 8030665-2018-00721
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• 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: 05/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Device Catalogue Number: 050-87216
• Device Lot Number: 17SR08026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT; PD SOLUTION