MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; PUMP, INFUSION, PCA

Catalog Number	21-7057-242
Medical Device Problem Codes	Collapse (1099); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing of the cadd administration set collapsed during infusion.This in turn led to under infusion.The nurse noted that there was medication left in the bottle after approximately 1.5 hours.The nurse changed the tubing and the medication ran fine on the new administration set.No serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One cadd high volume administration set was returned for evaluation.No discrepancies were found when device was visually inspected.The administration set underwent accuracy testing.The customer's complaint was unable to be confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7537112
• Report Number: 3012307300-2018-01743
• Device Sequence Number: 19287132
• Product Code: MEA
• UDI-Device Identifier: 10610586020407
• UDI-Public: 10610586020407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 21-7057-242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1