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

Model Number 57400

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation in process, no patient impact was reported.Customer was unable to provide any patient ica values but stated that quality control was in range before and after incident occured.

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

Device investigation: a nova biomedical technician performed a field service support follow-up visit to the user facility, and during inspection of the analyzer, the technician found that the sample probe s-line was kinked.The technician replaced the sampler assembly to correct the issue.Upon examination of the returned s-line to the manufacturer, a break was observed in the kinked section of the s-line.This break would prevent flow, cause errors, and the analyzer would not calibrate.Therefore, it is highly unlikely that the break was present during the time of the discrepant calcium results.Device history reviews (dhrs) were performed on the analyzer, s-line, and reference cartridge batches.No abnormalities were observed, and the dhrs indicated the released product met all specifications.Based on the available information, the complaint could not be confirmed.

• 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 3465
• MDR Report Key: 8959569
• MDR Text Key: 156758715
• Report Number: 1219029-2019-00045
• 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: 10/08/2019

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?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1