MAUDE Adverse Event Report: BYONYKS MEDICAL DEVICES INC BYONYKS X-1 APD CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	1B1207
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged event was confirmed by the servicing team.A visual inspection of the returned cycler exterior showed no sign of physical damage.The cause of the failure was the heater plate that failed to initiate the heating process.The cycler's safety systems functioned as intended and prevented the device from proceeding to the next therapy step.An investigation of the product history records was conducted.There were no issues identified with the heater plate during the manufacturing process.No patient injury or adverse outcome was reported.
Event or Problem Description
Peritoneal dialysis patient reported to technical support that during the bag heating process, the cycler didn't advance to the next step.The patient completed treatment with continuous ambulatory peritoneal dialysis with no complications.The device was replaced.

• Brand Name: BYONYKS X-1 APD CYCLER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BYONYKS MEDICAL DEVICES INC; 550 e devon ave ste 140; itasca IL 60143
• Manufacturer (Section G): BYONYKS PVT LTD; 45/a khayaban-e-iqbal; dha 3 xx block; lahore, punjab 54000 ; PK 54000
• Manufacturer Contact: eric flachbart ; 550 e devon ave ste 140; itasca, IL 60143 ; 8132605077
• MDR Report Key: 25592952
• Report Number: 3038277270-2026-00001
• Device Sequence Number: 5699919
• Product Code: FKX
• UDI-Device Identifier: 08964004471001
• UDI-Public: 0108964004471001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243371
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Repair
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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 Model Number: 1B1207
• Device Catalogue Number: 1B1207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic