MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. PHOX ULTRA COOX; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH,

Model Number 42013

Device Problems High Test Results (2457); Misassembly During Maintenance/Repair (4054)

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

Event Date 05/18/2019

Event Type  malfunction  

Manufacturer Narrative

No adverse event or patient impact was reported.Investigation ongoing.

Event Description

On (b)(6) 2019: customer reported high cl result for a patient in emergency department using a nova phox ultra coox analyzer when compared to the laboratory reference analyzer.

Manufacturer Narrative

The dhr reviews were performed including an assessment 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 service visit by nova technical support improper maintenance of instrument was discovered, the pump tubing was improperly attached at a waste bulkhead and pco2 cap had a small leak.The insufficient reference flow is the most probable root cause for low na and high cl results reported by the customer.The analyzer operated as intended once repairs were performed.The root cause is attributed to an operator error due to improper maintenance.Comparison study data obtained at the user facility was found to be comparable between the reference method, and another phox ultra analyzer.Moreover, the linearity testing shows that the phox ultra analyzer, sn (b)(4), performs as intended.The discrepant na and cl results could not be reproduced during linearity testing.

• Brand Name: PHOX ULTRA COOX
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH,
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• MDR Report Key: 8680646
• MDR Text Key: 148328247
• Report Number: 1219029-2019-00020
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 00385480420136
• UDI-Public: 00385480420136
• Combination Product (y/n): N
• PMA/PMN Number: K110648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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: 42013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 05/19/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1