MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	050-50758
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the complaint sample was returned to the manufacturer for a physical evaluation.During the disinfection of the sample a leak was found in the connection between the clear connector and the patient connector from the cycler set.The sample was visually inspected and an insecure connection between the connectors was found.The connection was not tight.That connection is performed by the customer and could be attributed to user error.The connection was reconnected until tight and no leaks were found.In addition, damage was found to the clear connector from the mts connector.However an underwater test was performed with a pressure of 20psi and no leaks was found.During the evaluation of the actual sample, the reported issue was confirmed.However, this could be attributed to user error since an insecure connection was found.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the stay safe pin of the patient liberty cycler set.The patient reported receiving an air detected in cassette alarm during drain 1 of 5 of treatment and the treatment was cancelled.Fluid did not come in contact with the cycler.The patient was advised to re-setup treatment with new supplies.Upon follow up, the patient stated they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that they were able to complete peritoneal dialysis treatment by resetting-up with new supplies.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cycler set used by the patient was reported to be available for return for physical evaluation by the manufacturer.

• Brand Name: STAY SAFE MTS SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 11926008
• Report Number: 8030665-2021-00950
• Device Sequence Number: 4395859
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Model Number: 050-50758
• Device Catalogue Number: 050-50758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER
• Patient Age: 68 YR
• Patient Weight: 57