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

Catalog Number	21-7083-24
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the cadd pump read "no cassette", but the cassette was inserted while using a cadd® administration set.No adverse events to the patient were reported.
Additional Manufacturer Narrative
Report source: (b)(6).One cadd extension set returned for analysis in used condition.Visual inspection of the pump shows the set was in good condition.Use testing was performed.Sample was connected and fully priming and the pump shows upstream occlusion alarm.The start tube engagement with the pump tube is more than 0.375 inches.This spec is out according to procedure (b)(4).The customer complaint was confirmed.The root cause is most probable the star tube bond engagement is out of specification.Engineering will retrain the production personnel to reinforce assembly of the pump tube.No reported adverse effects.

• 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: 7579930
• Report Number: 3012307300-2018-02083
• Device Sequence Number: 16214099
• Product Code: FPA
• UDI-Device Identifier: 30610586021521
• UDI-Public: 30610586021521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991301
• 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): 10/02/2018

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: Health Professional
• Device Expiration Date: 05/25/2022
• Device Catalogue Number: 21-7083-24
• Device Lot Number: 47X347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1