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	07/30/2023
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
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the second connector on the patient line during their pd treatment.The patient reported receiving an air detected in cassette alarm during fill 1 of treatment and the treatment was cancelled.The patient was advised to reset up treatment with new supplies.Upon follow up, it was confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient noted that the blue ring folded when the connector was screwed on.Confirmed no fluid came in contact with the cycler.The patient was prescribed prophylactic antibiotics, however, despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The cycler set used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the second connector on the patient line during their pd treatment.The patient reported receiving an air detected in cassette alarm during fill 1 of treatment and the treatment was cancelled.The patient was advised to reset up treatment with new supplies.Upon follow up, it was confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient noted that the blue ring folded when the connector was screwed on.Confirmed no fluid came in contact with the cycler.The patient was prescribed prophylactic antibiotics, however, despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The cycler set used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
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 from the second connector on the patient line during their pd treatment.The patient reported receiving an air detected in cassette alarm during fill 1 of treatment and the treatment was cancelled.The patient was advised to reset up treatment with new supplies.Upon follow up, it was confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient noted that the blue ring folded when the connector was screwed on.Confirmed no fluid came in contact with the cycler.The patient was prescribed prophylactic antibiotics, however, despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The cycler set used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Correction provided in h6.

• 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: 17481393
• Report Number: 0008030665-2023-00716
• Device Sequence Number: 16770594
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/24/2023
• 2 Devices were Involved in the Event: 1 2

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: 12/31/2025
• Device Catalogue Number: 050-50758
• Device Lot Number: 22SR08085
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 10/24/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/10/2023; 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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.; DELFLEX PD FLUID.; LIBERTY CYCLER SET .; LIBERTY CYCLER SET .; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Sex: Male