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	STAY SAFE MTS SET
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis (pd) patient reported that there was fluid found leaking from the patient line connection during pd treatment.Fluid was found leaking during dwell 1 of 5.There were no holes noted.There was no fluid inside the cycler module area.In a follow up, the patient's roommate said the patient did not have any harm or adverse event due to the leak.In another follow up, the pd nurse verified there was no harm.The multiple tubing segment is not available to return.
Additional Manufacturer Narrative
Plant investigation: the complaint sample is not available for manufacturer physical evaluation.At this time a search in the sap system was performed to verify product availability for alternate samples at the distribution centers.According to the sap system no product is available of the lots delivered to the patient, on distribution centers to be analyzed.The entire lots have been sold and distributed; please see attachment a, for stock search.Since the complaint sample is not available neither photos or videos were provided for evaluation and during the dhr (device history record) review of the lots involved does not show any non-conformances, deviations or associated rework related to the alleged complaint description, could not be confirmed.No sample has been provided.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
A peritoneal dialysis (pd) patient reported that there was fluid found leaking from the patient line connection during pd treatment.Fluid was found leaking during dwell 1 of 5.There were no holes noted.There was no fluid inside the cycler module area.In a follow up, the patient's roommate said the patient did not have any harm or adverse event due to the leak.In another follow up, the pd nurse verified there was no harm.The multiple tubing segment is not available to return.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 20090024
• Report Number: 0008030665-2024-00733
• Device Sequence Number: 18032781
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: STAY SAFE MTS SET
• 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: 08/18/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Unknown