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

Model Number	050-87222
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer, preventing a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, the reported issue could not be confirmed and a definitive conclusion regarding the reported incident could not be reached.
Event or Problem Description
It was reported by a patient contact that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.The patient received an air detected in cassette alarm, an m84 pump error alarm, and a make sure the heather bag (hb) is on the heater tray (ht) message during fill 6 of 6 of treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.It was reported that the cycler made a loud popping noise throughout all phases of the patient's treatment.The patient was advised to discontinue the use of their cycler and a new cycler was issued to the patient.The patient reverted to an alternate form of treatment.The patient was also advised to follow up with their peritoneal dialysis nurse (pdrn).There was no adverse event, serious injury, nor medical intervention reported during the initial call.Additional information was requested, however, to date a response has not been received.The return of the cycler to the manufacturer was scheduled as well as the delivery of its replacement to the patient.The cycler set used by the patient was not returned to the manufacturer.

• Brand Name: LIBERTY PDX, INTEGRATED 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: 10840317
• Report Number: 8030665-2020-01671
• Device Sequence Number: 19867354
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 050-87222
• Device Catalogue Number: 050-87222
• Device Lot Number: 20AR08128
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1