MAUDE Adverse Event Report: NIPRO RENAL SOLUTIONS USA CORPORATION MEDICALYTE; BICARBONATE CONCENTRATE SOLUTION FOR DIALYSIS

Model Number	BC+201
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr reportability determined during re-evaluation of complaints under class 1 recall for bacterial and fungal contaminants (fda recall number: z-1730-2025).
Event or Problem Description
Customer reported foreign substance found in the liquid bicarb.No patient use.

• Brand Name: MEDICALYTE
• Common Device Name: BICARBONATE CONCENTRATE SOLUTION FOR DIALYSIS
• Manufacturer (Section D): NIPRO RENAL SOLUTIONS USA CORPORATION; 509 fishing creek rd; lewisberry PA 17339
• Manufacturer (Section G): NIPRO RENAL SOLUTIONS USA CORP; 509 fishing creek rd.; lewisberry PA 17339
• Manufacturer Contact: jessica oswald-mcleod ; 509 fishing creek rd; lewisberry, PA
• MDR Report Key: 22122927
• Report Number: 1528807-2025-00025
• Device Sequence Number: 7062522
• Product Code: KPO
• UDI-Device Identifier: 00817411022824
• UDI-Public: 817411022824
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: Health Professional
• Device Expiration Date: 07/18/2026
• Device Model Number: BC+201
• Device Lot Number: N4G015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1730-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown