MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN- FMC PRODUCT; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	UNKNOWN-FMCPRODUCT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
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 on the floor during their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 3 of 3 of treatment.The warning occurred multiple times.The patient stated that the baxter bag came loose and fluid leaked onto the floor.The patient noted that the baxter bag was empty.The patient elected to continue with treatment unless the alarm occurred again.Upon follow up, the patient stated that the adaptor has a poor design and does not attach to the baxter bag properly.The adaptor fell off during treatment causing the baxter bag to leak all over his floor.The patient was able to complete treatment.There was no patient serious injury or medical intervention required as a result of this event.The adaptor was discarded and not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the floor during their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 3 of 3 of treatment.The warning occurred multiple times.The patient stated that the baxter bag came loose and fluid leaked onto the floor.The patient noted that the baxter bag was empty.The patient elected to continue with treatment unless the alarm occurred again.Upon follow up, the patient stated that that the adaptor has a poor design and does not attach to the baxter bag properly.The adaptor fell off during treatment causing the baxter bag to leak all over his floor.The patient was able to complete treatment.There was no patient serious injury or medical intervention required as a result of this event.The adaptor was discarded and not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Corrected information provided in d1, d4, d10, and g4.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the floor during their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 3 of 3 of treatment.The warning occurred multiple times.The patient stated that the baxter bag came loose and fluid leaked onto the floor.The patient noted that the baxter bag was empty.The patient elected to continue with treatment unless the alarm occurred again.Upon follow up, the patient stated that the adaptor has a poor design and does not attach to the baxter bag properly.The adaptor fell off during treatment causing the baxter bag to leak all over his floor.The patient was able to complete treatment.There was no patient serious injury or medical intervention required as a result of this event.The adaptor was discarded and not available to be returned to the manufacturer for physical evaluation.
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 the effected product shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances 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.

• Brand Name: UNKNOWN- FMC PRODUCT
• 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 ; 6174175172
• MDR Report Key: 23302897
• Report Number: 0008030665-2025-02467
• Device Sequence Number: 4863769
• Product Code: KDJ
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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: UNKNOWN-FMCPRODUCT
• Device Lot Number: 25CR08118
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/24/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/05/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2025
• 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 CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; STAY SAFE/LUER LOCK ADAPTER 4 IN.; STAY SAFE/LUER LOCK ADAPTER 4 IN.
• Patient Sex: Male