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

Catalog Number	21-7091-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the event occurred some time between (b)(6) 2017.The exact date is unknown.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that before changing the perfusion bag, air bubbles were present in the tubing of a cadd administration set.The fault was noticed when the pump alarmed and displayed the message: "air bubbles in tube".The tubing was purged, but the bubbles then appeared in the cassette.No injury was reported.
Additional Manufacturer Narrative
One cadd® administration set was received for analysis in used condition.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.The sample was received with part of the tube filled of dried medication and a delamination was found in the bonding between the pump tube and the 82" tube.Water was infused through the assembly then was connected to a pump.The sample could not be primed due to the dried medication impeding the flow of water.An alarm sounded with message "downstream occlusion.Clear occlusion between pump and patient." a leak was detected from the bonding where the delamination was found.Prior to packaging, a sample of 32 units were taken to perform a visual inspection to verify for any damages, workmanship defect and solvent bond.No discrepancies were found.Four (4) samples from inventory were subjected to the accuracy test.No discrepancies were detected.All units passed.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode was determined to be "improperly assembled".The root cause was determined to be "manufacturing".

• 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: 6711879
• Report Number: 3012307300-2017-01472
• Device Sequence Number: 919750
• Product Code: FPA
• UDI-Device Identifier: 10610586024160
• UDI-Public: 10610586024160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 09/28/2021
• Device Catalogue Number: 21-7091-24
• Device Lot Number: 46X689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1