MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE PRIME CCS ANALYZER SYSTEM; BLOOD/GAS/ELECTROLYTE/METABOLITE/ CO-OXIMETRY ANALYZER

Model Number	PRIME CCS COMP
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The operator of the device sustained eye exposure to flush fluid when attempting to clear a visible clot in the probe of the analyzer.The operator was not wearing eye protection.
Additional Manufacturer Narrative
Operator was wearing only lab coat and gloves as protective equipment.The ifu (section 7) troubleshooting clearly highlights the following warning: "warning: blood samples and blood products are potential sources of infectious agents.Handle all blood products, accessories, and flow path components (waste-line, capillary adaptor, probe, sensor cartridge, etc.) with care.Gloves and protective clothing are recommended.When performing maintenance and troubleshooting procedures, also use protective eyewear." retraining and reinforcement of saftey practices was provided to the facility.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• Brand Name: STAT PROFILE PRIME CCS ANALYZER SYSTEM
• Common Device Name: BLOOD/GAS/ELECTROLYTE/METABOLITE/ CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 4 enterprise rd; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 15952812
• Report Number: 1219029-2022-00047
• Device Sequence Number: 15288890
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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 Model Number: PRIME CCS COMP
• Device Catalogue Number: 53657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Female