MAUDE Adverse Event Report: BD/CAREFUSION 303 INC. SET ADMINISTRATION INTRAVASCULAR

Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient required blood transfusion.Three alaris modules and two sets of blood tubings failed to work properly with the "air-in-line" alarm, although there weren't bubbles apparent in the tubing.Delay of initiating transfusion, but did not negatively impact patient.

• Brand Name: SET ADMINISTRATION INTRAVASCULAR
• Common Device Name: SET ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): BD/CAREFUSION 303 INC.
• MDR Report Key: 8646084
• Report Number: MW5086930
• Device Sequence Number: 2473186
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: (01)07613203011310
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/23/2019
• 3 Devices were Involved in the Event: 1 2 3

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 89