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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS INC. ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM INJECTOR HEAD; INJECTOR AND SYRINGE, ANGIOGRAPHIC
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ACIST MEDICAL SYSTEMS INC. ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM INJECTOR HEAD; INJECTOR AND SYRINGE, ANGIOGRAPHIC Back to Search Results
Model Number CVI 14657
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Event Description
Situation: the air sensor of the acist angiographic injector malfunctioned.When air bubbles are detected the injector normally shuts down and displays a warning.Air bubbles were detected in one of the angiograms performed.The injector was used twice prior to the event without any issues.Biomed personnel were informed of the event and the equipment was removed from the lab for further inspection.Background: acist devices is a contrast power injector used for angiography in cardiac cath lab assessment: air was not detected by device sensor.Recommendation: technician reached out to vendors and biomed.Vendors will bring loaner device while doing an inspection.Current workflow for device should remain the same unless vendor recommends other safety steps.There was no harm in this event.
 
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Brand Name
ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM INJECTOR HEAD
Type of Device
INJECTOR AND SYRINGE, ANGIOGRAPHIC
Manufacturer (Section D)
ACIST MEDICAL SYSTEMS INC.
7905 fuller road
eden prairie MN 55344
MDR Report Key12216895
MDR Text Key263133936
Report Number12216895
Device Sequence Number1
Product Code DXT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCVI 14657
Device Catalogue Number700706-009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2021
Event Location Hospital
Date Report to Manufacturer07/23/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age6570 DA
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