MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD LEGACY; PUMP, INFUSION

Model Number 6500

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Information on a smith medical cadd administration sets - flow stop underinfused.The infuson was to run 250 ml for 46 hours and according to (b)(6) medical center - (b)(6) , the patients would return with 15-30 ml remaining, even when pump read "res vol empty." no patient adverse events reported.Unknown medication to that was infused, however the 250 ml may not account for volume of medication that was inserted into bag.This could account for extra volume.

• Brand Name: CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 9772603
• MDR Text Key: 181537318
• Report Number: 3012307300-2020-01602
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019647
• UDI-Public: 10610586019647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1