MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7109-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical cadd extension set had overinfused.The programmed settings were 2ml/ hr, with a total volume of 90 ml over 46 hours.10 ml were reportedly remaining.Tubing was noted to have disconnected from 100 ml cassette.No patient injury resulted.

• Brand Name: CADD® EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7736744
• Report Number: 3012307300-2018-02885
• Device Sequence Number: 16837046
• Product Code: FPA
• UDI-Device Identifier: 10610586034497
• UDI-Public: 10610586034497
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 02/14/2022
• Device Catalogue Number: 21-7109-24
• Device Lot Number: 57X053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70