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

Catalog Number	21-7023-24
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This device is same and/or similar to a device approved for distribution in the us.
Event or Problem Description
It was reported that a cadd® administration set caused the pump to alarm "upstream occlusion".This occurred during use after the set-up of the cassette and the infusion tube, which was noted as being "very difficult".The alarm was cleared after replacing the infusion tube.No injury was reported.
Additional Manufacturer Narrative
One cadd® cadd® administration set was returned in used condition.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The join between the star tube and the pump tube was detached from the housing.No marks of solvent were found in this part of the product.No obstructions were detected in any of the joins.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode could not be duplicated.The most probable root cause is that the tubing detached activated the sensors on the pump for an occlusion alarm.

• Brand Name: 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: 7328509
• Report Number: 3012307300-2018-00535
• Device Sequence Number: 1630523
• Product Code: FPA
• UDI-Device Identifier: 10610586019821
• UDI-Public: 10610586019821
• Combination Product (Y/N): N
• 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): 07/03/2018

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: 06/30/2022
• Device Catalogue Number: 21-7023-24
• Device Lot Number: 47X434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1