MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, 105", SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7024
Medical Device Problem Codes	Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that an administration set connected to a smiths medical cadd infusion pump would not prime and would cause the pump to give an error message about an upstream occlusion.There were no adverse events reported.

• Brand Name: SET, ADMIN, CADD, 105", SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9564664
• Report Number: 3012307300-2020-00279
• Device Sequence Number: 16766728
• Product Code: FPA
• UDI-Device Identifier: 10610586019852
• UDI-Public: 10610586019852
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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 Expiration Date: 08/14/2024
• Device Model Number: 7024
• Device Catalogue Number: 21-7024-24
• Device Lot Number: 3857625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1