MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP., NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM; ELECTRODE MEASUREMENT, BLOOD GASES (PCO2, PO2) AND BLOOD PH

Health Effect - Clinical Codes	Septic Shock (2068); Patient Problem/Medical Problem (2688); Full thickness (Third Degree) Burn (2696)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently ongoing.(b)(6).
Event or Problem Description
Patient received a blood transfusion based upon hematocrit and hemoglobin (hct & hb) results obtained from the prime ccs analyzer.See supplemental report.
Additional Manufacturer Narrative
Additional information provided by the facility indicates the 'transfusion cut off is 21% for hematocrit level.The hematology analyzer value result from (b)(6) 2017 6:43pm was 24%.The patient would not have been given the transfusion based on the facility reference analyzer result.Investigation is currently in progress.Additional supplemental report will be submitted upon completion.

• Brand Name: NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.,; 200 prospect street; waltham MA 02454
• MDR Report Key: 6479646
• Report Number: 1219029-2017-00003
• Device Sequence Number: 1267361
• Product Code: CHL
• UDI-Device Identifier: 00385480534185
• UDI-Public: 00385480534185
• Combination Product (Y/N): N
• PMA/510(K) Number: K131703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR