MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE PRIME CCS COMP W/ SCANNER ANALYZER; BLOOD ANALYZER

Catalog Number	53657
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/14/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The analyzer and sensor cards from the same lot are expected to be returned for investigation.Troubleshooting performed after the incident indicates the sensor card was exchanged and disposed of.A local technician was sent to the site to check the equipment ( pco2 calibration slopes and calibration slope).A full investigation will be performed upon receipt of the returned product.Further information regarding patient condition as well as any co-morbidities was requested however, not expected to be forthcoming.
Event or Problem Description
On (b)(6) 2024 patient was admitted with an aneurysm and underwent cardiac surgery to place valves (unspecified).Low pco2 result incompatible with the patient's clinic.Patient expired thursday evening (b)(6) 2024.
Additional Manufacturer Narrative
The returned database was reviewed and the suspect low pco2 result was confirmed.Two (2) levels of qc measured at 6am were in range.The qc measured immediately after the suspect patient sample analysis failed out of range.It is recommended, per label copy, that one level of control be measured during each 8 hours of testing.A retained sensor card from lot 24163017 was tested on a prime ccs and r&d could not reproduce the discrepant low pco2 results.The returned analyzer and 3 sensor cards were received on 12/30/2024.An electrical test was performed on 1/9/2025 with no issues.A final system test was performed on 1/10/2025 with no issues.Two of the returned sensor cards had a use life expiration of 2024-10-27 and one had their use life expiration as 2024-11-03, therefore they could not be used for final system test.A new sensor card, pn 42033, ln 24344032 was used.A root cause could not be conclusively determined as the reported results could not be replicated.The analyzer passed final system test as well as the electrical test.Had qc been run more frequently, as recommended in the ifu, it is likely qc would have failed prior to the result in question and alerted the customer to stop testing and contact nova support.No further action is recommended at this time.Nova biomedical will continue to monitor for this or similar events.

• Brand Name: STAT PROFILE PRIME CCS COMP W/ SCANNER ANALYZER
• Common Device Name: BLOOD ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 4 enterprise rd; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 20511410
• Report Number: 1219029-2024-00006
• Device Sequence Number: 7203528
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 53657
• Device Lot Number: 24163017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Female