MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; Set, Administration, For Peritoneal Dialysis, Disposable

Catalog Number	050-95018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient contact reported to fresenius medical care (fme) technical service (ts) on (b)(6) 2026 that the liberty cycler alarmed with an m31 air detected in cassette warning in fill 5 of 5.The patient (pt) was connected during incident and fluid was seen.Upon follow-up conducted on (b)(6) 2026 the patient contact stated that on (b)(6) 2026 the patient¿s liberty cycler started to alarm with m31 air detected in cassette warning in fill 5 of 5.The patient contact stated that after disconnecting the patient from the cycler with the assistance of the fresenius technical support the patient noticed that there was some fluid on the floor.The contact confirmed that the patient uses and that they were using a 7.25% baxter solution bag (lot unknown) for the last fill.The contact stated that the fluid leaked from the connection of the luer lock connector to the cassette.Per patient contact there were no external leaks from the fresenius solution bag or any connections prior, during, or after the event.The patient contact also confirmed that there was no fluid intrusion inside the cycler as the result of the reported event.The contact stated that they did not know what caused the leak and confirmed that there were no known delivery issues or damage to the delivery boxes the solutions and supplies were delivered in.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient was not able to complete treatment on the day of the reported event.The patient was able to resume treatment on the cycler with no further issues the following day.The sample is not 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.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• Common Device Name: Set, Administration, For Peritoneal Dialysis, Disposable
• 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 ; +1(617)417-5172
• MDR Report Key: 50458030
• Report Number: 0008030665-2026-02299
• Device Sequence Number: 13328057
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95018
• Device Lot Number: 26AR08078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2026
• 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: Baxter PD Fluid; Liberty Cycler Set; Liberty Select Cycler
• Patient Sex: Unknown