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

Catalog 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	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the patient line of the cycler set during drain 1 of 5 of their pd treatment.The patient reported receiving a draining slowly alarm during drain 1 of 5 of treatment prior to the leak.The blue pin that is closest to the patient was not pushed in but somehow the connector was cracked.The patient used an extension set with three connectors; however, the first connector was cracked resulting in the fluid leak.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was advised to re-setup the cycler with new solution bags and new tubing set.Upon follow up, the patient contact confirmed the reported fluid leak event occurred from a crack at the connection between the port on the patient and the extension set.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using new supplies and the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set and extension set are available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: as the device was not returned to the manufacturer, 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, 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 on the patient line of the cycler set during drain 1 of 5 of their pd treatment.The patient reported receiving a draining slowly alarm during drain 1 of 5 of treatment prior to the leak.The blue pin that is closest to the patient was not pushed in but somehow the connector was cracked.The patient used an extension set with three connectors; however, the first connector was cracked resulting in the fluid leak.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was advised to re-setup the cycler with new solution bags and new tubing set.Upon follow up, the patient contact confirmed the reported fluid leak event occurred from a crack at the connection between the port on the patient and the extension set.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using new supplies and the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set and extension set are available to be returned to the manufacturer for physical 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
• 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: 21565016
• Report Number: 0008030665-2025-00558
• Device Sequence Number: 9216520
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 050-50758
• Device Lot Number: 24SR08076
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2024
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 134 KG