MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE PRIME PLUS ANALYZER; BLOOD GAS ANALYZER

Catalog Number	57400
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sodium result incompatible with the patient's clinical data.
Additional Manufacturer Narrative
" the patient was hospitalized due to neurological conditions and acute renal dysfunction.She had high sodium levels and was receiving therapeutic measures to control sodium.On (b)(6) 2025, the sodium level was 140, which is within the normal range.All sodium control measures were suspended, as this should be gradual due to the associated risk of worsening of the neurological condition.A maximum of 12 meq/l/day is considered safe, and the variation was 26 meq/l/day.On (b)(6) 2025, a new result identified sodium levels of 178 meq.After the result on (b)(6) 2025, therapeutic measures to correct hypernatremia were immediately resumed, and sodium was serially measured every 6 hours.' an investigation is currently in process.A supplemental report will be submitted upon completion of the investigation.No reported sequelae as a result of this issue.
Additional Manufacturer Narrative
The customer database was reviewed.Patient sample measured on (b)(6) 2025 at 6:10 am with a na result of 140.2 mmol/l was observed.Qc results prior to patient sample measurement were within established limits.Qc results after sample measurement were out of range.In addition to the qc results, multiple flow errors were found in the review of the event log as far back as 3/3/2025.There were multiple instances of obc l1 not detected and frequent hct instability and out of range errors.Retain sensor lot: 24209053 was installed on a prime plus analyzer in r&d.Slope and qc values for na (sodium) were within acceptable limits.Two whole blood precision runs were performed, and both passed acceptance criteria.As there were a significant number of flow and air detector related issues found in the event log and there were also multiple instances of out-of-range hct results, this suggests that improper aspiration and position of samples may have occurred.The flow issues were resolved after the cleaning of probe/s-line assembly.Since this analyzer runs a high number of samples per day, it is suggested that more frequent maintenance including s-line replacement and flushing of flow path be performed.Such improved maintenance should prevent such flow related result occurrences in the future.Nova brazil will contact the customer to provide enhanced maintenance training and will support the customer for any such flow related issues in the future.Based on testing of similar sensors, the bias observed by the customer could not be reproduced.While the exact case could not be reproduced, it is speculated the issue that occurred could have been due to a flow related issue that could be prevented with enhanced maintenance performance.Dhr reviews were performed on the reported analyzer and sensor card lot.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02453
• 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: 21952903
• Report Number: 1219029-2025-00003
• Device Sequence Number: 8554063
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K221900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2018
• 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: 52 YR
• Patient Sex: Female