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

Model Number 57400

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Misassembly During Maintenance/Repair (4054)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2019

Event Type  malfunction  

Manufacturer Narrative

During a service visit nova's technician discovered that reference sensor was installed incorrectly: the sensor was not seated properly.Investigation is ongoing.

Event Description

Customer reported discrepant ionized calcium result using nova stat profile prime plus analyzer, sn (b)(4) when compared to other prime plus analyzer.No adverse event was reported.

Manufacturer Narrative

Dhr reviews were performed including an assessement of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were observed.The dhr indicated that the released product met all specifications.During the field service support follow-up visit, the nova biomedical technician discovered that the reference cartridge was not seated.The technician reseated the reference sensor and primed the fluids.The instrument was calibrated four (4) times and controls were analyzed.The customer reported the reference pump tubing was being pulled tightly through the pump due to a detached retaining collar.However, it was determined that the reference pump tubing did not contribute to the discrepant results, based on the fact that other reference dependent results were normal.Testing of a retained sensor card from the same lot met the acceptance criteria and no erroneous results were observed.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• MDR Report Key: 8959572
• MDR Text Key: 166972645
• Report Number: 1219029-2019-00047
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (y/n): N
• PMA/PMN Number: K180428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1