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

Device Problem Inability to Irrigate (1337)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/22/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 305240033
• Report Number: 1219029-2022-00047
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female