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

Catalog Number	21-7091-24
Medical Device Problem Codes	Leak/Splash (1354); Delamination (2904); 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 returned for analysis in a used condition.The tubing was partially filled dried medication as well as delamination was found in the bonding between the pump tubes upon visual exam.Functional testing performed by infusing water through the assembly and connecting into a cadd solis pump in order to reproduce the failure; noting micro air bubbles on the line and leakage from the bonding where delamination was detected.Relevant documents were reviewed and deemed adequate.Manufacturing process and operations were reviewed finding no discrepancies.Prior to packaging, a sample of 32 units was taken in order to perform a visual inspection to verify for any damages, workmanship defect and solvent bonds; finding no discrepancies.Accuracy testing on four samples were tested using a balance melted toledo; passing testing.Based on the evidence, the root cause is that the delamination caused the air infiltrate.

• 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: 6711882
• Report Number: 3012307300-2017-01471
• Device Sequence Number: 1508849
• 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: 07/28/2021
• Device Catalogue Number: 21-7091-24
• Device Lot Number: 46X555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• 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: 04/25/2018
• 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