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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius stay safe mts set shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.In addition the insert label that is included in the packaging of the product contains indications and warnings to perform the connection.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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 the multi segment connector during fill 1 of 3 of their pd treatment.The patient reported receiving an air detected in cassette alarm during drain 0 of 3 of treatment.The patient reported that three or four air bubbles were found in the drain line.The patient contacted technical support for assistance with bypassing to fill 1 because they were empty.It is unknown at which point in therapy the leak may have begun.The patient reported that the cause of the leak was a loose connection of the multi segment connectors.The patient reported that fluid leak consisted of 4 drops of liquid.The fluid leak did not come in contact with the cycler.The patient was advised to reset up their cycler, but the patient refused.The patient tightened the multi segment connector and that had resolved the problem.The patient was able to complete fill 1 and continue their treatment.Upon follow up, the patient stated that they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient stated that they were able to complete treatment.The patient stated that the fluid leak originated from the multi segment connector.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The stay safe mts set used by the patient was discarded and is not 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: 10583515
• Report Number: 8030665-2020-01405
• Device Sequence Number: 11565281
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• 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): 09/24/2020

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 Model Number: 050-50758
• Device Catalogue Number: 050-50758
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 79