MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	30883
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse was unable to get pca tubing to prime.Manufacturer response for pca tubing, bd pca administration set (per site reporter).Quality event report emailed to customer feedback .Return email received from customer advocacy complaint management.Complaint file (b)(4).Product returned.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 10032218
• Report Number: 10032218
• Device Sequence Number: 2614193
• Product Code: FPA
• UDI-Device Identifier: 10885403273957
• UDI-Public: (01)10885403273957
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2020
• Report Date (Section F): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30883
• Device Catalogue Number: 30883
• Device Lot Number: (10) 19115225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 58
• Date Report Sent to FDA: 05/05/2020