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

Model Number PRIME CCS COMP

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

The customer is reporting variable results for pco2 on their prime analyzer.No patient harm or intervention was reported.

Manufacturer Narrative

Udi: (b)(4).The user reported an incident with discrepant patient results when compared to a reference analyzer while measuring pco2 with a statprofile prime ccs comp analyzer, serial number (b)(6).This event occurred on (b)(6) 2022.A formal investigation was unable to be performed due to the lack of returned sensor card(s) from china.A copy of the analyzer's database was returned to nova product development and reviewed.The database did not identify a root cause for the alleged result discrepancy.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the root cause for the alleged result discrepancy was unable to be identified, and if additional information becomes available, it will be reviewed to determine if additional investigation is warranted.Nova will continue to monitor for recurrence of similar events.

• Brand Name: STAT PROFILE PRIME CCS COMP
• Type of Device: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 14014669
• MDR Text Key: 288614681
• Report Number: 1219029-2022-00037
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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
• Device Operator: Health Professional
• Device Model Number: PRIME CCS COMP
• Device Catalogue Number: 53657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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