MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. BT2000 AUTOMATED MANIFOLD KIT; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	014613
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Air errors on the machine.We pulled the lot and will return to the manufacturer.The machine erred "air bubble detected." the department decided to pull all of the inventory with that lot number.They had more than one patient--cannot state how many.They have had other issues with this alarm but the device had recently returned from the manufacture from repair and it alarmed on the next patient it was used on.After contacting the manufacture they confirmed they had not replaced the part but that in their paperwork they noted they would replace it if we had the same errors again.It was sent to the manufacture for repair with that error.They (the devices) have been returned to the manufacture.

• Brand Name: BT2000 AUTOMATED MANIFOLD KIT
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 8944508
• Report Number: 8944508
• Device Sequence Number: 2559641
• Product Code: DXT
• UDI-Device Identifier: 10841716101974
• UDI-Public: (01)10841716101974
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• Report Date (Section F): 07/25/2019

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
• Operator of Device: No Information
• Device Model Number: 014613
• Device Catalogue Number: 014613
• Device Lot Number: 02119H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/25/2019