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

Catalog Number	026-20226
Health Effect - Clinical Code	Death (1802)
Date of Event	07/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
A peritoneal dialysis patient's nurse reported that on (b)(6) 2017, the patient coded and subsequently expired on a liberty cycler.There is no temporal association between the patients¿ death and liberty cycler and the liberty cycler set.There is confirmed patient completion of the ccpd treatment.There is no documentation supporting a possible association between the liberty cycler, the liberty cycler set and the expiration of the patient.

• Brand Name: LIBERTY CYCLER DRAIN SET
• Common Device Name: 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: 6772349
• Report Number: 8030665-2017-00539
• Device Sequence Number: 221004
• Product Code: FKX
• UDI-Device Identifier: 00840861100620
• UDI-Public: 00840861100620
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K811986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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
• Operator of Device: No Information
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 026-20226
• Device Lot Number: 17AR08135
• Was Device Available for Evaluation?: No
• Device Age: MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR
• Patient Weight: 82