MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE PRIME PLUS® ANALYZER; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Catalog Number	57400
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	Hyperkalemia (4824)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service visit was initiated.The technician discovered the ceramics manifold was leaking pink fluid inside.The rotary valve ceramics were replaced.The analyzer was left in working condition.Multiple attempts were made to the customer to obtain additional details to help ascertain root cause, on 2/10 and 2/18, with no response.A dhr (device history record) review was performed on the reported analyzer.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.No further action is recommended at this time.Nova biomedical will continue to monitor for this or similar events.
Event or Problem Description
Per customer: "i am writing to report that our nova stat profile prime plus was completely nonfunctional today, which significantly impacted patient testing and workflow in our laboratory.This downtime directly affected patient care.We had a stat patient with suspected hyperkalemia, and we were unable to provide critical potassium results to the provider due to the instrument failure.This situation posed a serious risk to timely clinical decision-making." a follow up with the customer indicated the analyzer had been down all day and after consumables were replaced the analyzer has been busy priming/calibrating and most of the test are locked out.The audit log indicated slope errors on several parameters.

• Brand Name: STAT PROFILE PRIME PLUS® ANALYZER
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 4 enterprise rd; billerica MA 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 24570256
• Report Number: 1219029-2026-00018
• Device Sequence Number: 8384169
• Product Code: CHL
• UDI-Device Identifier: 10385480574003
• UDI-Public: (01)10385480574003(11)250103
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: Health Professional
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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 Sex: Unknown