MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD LEGACY 6500; PUMP, INFUSION

Model Number 6500

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

Investigation results completed on a cadd legacy 6400 pump.Event log opened and no evidence to support complaint of failed accuracy -8 %.When tests done to duplicate complaint, it was not verified and the device fell within specification of +/-6%.Device physical condition was good.No actions taken, as no fault could be found.Unknown cause of event and device passed all delivery and functional testing.

Event Description

Information received on a smiths medical cadd legacy 6400 pump failed accuracy -8.4%.Incident occured while testing and no patient involvement.

• Brand Name: CADD LEGACY 6500
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9633661
• MDR Text Key: 176496414
• Report Number: 3012307300-2020-00583
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2020

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
• Device Operator: Other
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1