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

Catalog Number	21-7036-01
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a cadd® cadd® administration set caused a cadd pump to alarm "upstream occlusion".No visualized defect noted.No adverse events to the patient.The product concern was noted prior to use.
Additional Manufacturer Narrative
One cadd administration sets was returned for analysis.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The sample received was visually inspected and no abnormality were detected.Functional test on the sample was performed using a pump cadd solis to look for unusual functions; and the sample was connected, and it was recognized without difficult and the pump was set running and alarm did not activate.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and the alarm was not activated.No corrective actions are required since the complaint was not confirmed.However, production personnel were notified by quality engineer as awareness of the defect reported by the customer.

• Brand Name: CADD® CADD® ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7883672
• Report Number: 3012307300-2018-03876
• Device Sequence Number: 16603577
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: Health Professional
• Device Expiration Date: 02/09/2023
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 48X100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1