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	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples tested positive for cladosporium sphaerospermum and rhodotorula mucilaginosa.
Event or Problem Description
Dark colored debris moving around unopened bicarbonate solution while preparing for dialysis treatment.Solution with debris was not used for patient treatment and remaining solution from the same lot was checked and no other bottle was found to have debris.

• 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: 22134120
• Report Number: 1528807-2025-00040
• Device Sequence Number: 7445261
• Product Code: KPO
• UDI-Device Identifier: 00817411022824
• UDI-Public: 817411022824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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 Model Number: BC+201
• Device Lot Number: N4M013
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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