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	02/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.The ups tracking number was verified and no information was found that the customer sent the sample for return.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, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from their multi-tubing set (mts) during pd treatment.The patient reported receiving an air detected in cassette alarm during drain 1 of 7 of treatment and the treatment was canceled.No fluid came in contact with the cycler and no air bubbles were detected during setup.It was reported the patient would cancel treatment and re-setup with new supplies.Upon follow-up, the patient confirmed that the leak occurred from the mts only and no leak was found from the cassette lines or cycler.The patient confirmed that they did not develop any symptoms, injury, adverse event, or require medical intervention as a result of the reported event.The patient is trained on performing manuals and stat drains if needed, and was able to complete treatment by resetting up with new supplies.The mts was reported to be available for return to the manufacturer for evaluation.

• 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: 11416638
• Report Number: 8030665-2021-00294
• Device Sequence Number: 3631638
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/04/2021

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 Expiration Date: 10/31/2023
• Device Model Number: 050-50758
• Device Catalogue Number: 050-50758
• Device Lot Number: 20NR08117
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60