MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7302-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating this cadd cassette was alarming on patient's both the pump.The reported event did not cause any adverse effects to the patient.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8505278
• Report Number: 3012307300-2019-01484
• Device Sequence Number: 1515695
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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 Expiration Date: 10/23/2023
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3716369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 63