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

Model Number	SET, ADMIN, CADD, SPIKE C
Medical Device Problem Codes	Connection Problem (2900); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medial cadd administration cassette would not attach to pump and only did after changing tubing.This alarm occured multiple times, interrupting therapy.No patient adverse events reported.

• Brand Name: CADD ADMINISTRATION CASSETTE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis MN 55442
• MDR Report Key: 9555385
• Report Number: 3012307300-2020-00035
• Device Sequence Number: 19273219
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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: Health Professional
• Device Expiration Date: 06/04/2024
• Device Model Number: SET, ADMIN, CADD, SPIKE C
• Device Catalogue Number: . 21-7036-01
• Device Lot Number: 3823950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1