MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY ONE AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 6400

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the device exhibited last error codes 1260 and 1261 and had lcd artifacts present.The event occurred during testing.There was no patient involvement and no patient harm reported.

Manufacturer Narrative

Event date unknown.One device was returned for evaluation.Visual inspection revealed the lcd display was damaged and lens display was foggy.The overlay keypad, downstream sensor and upstream sensor seal were contaminated.The event history log was unable to be downloaded due to alarm message error code 1260 on the pump display.Functional testing was able to replicate the reported issue; the mcu board clock battery was damaged as well as the lcd display.The most probable root cause was determined to be the mcu board clock batteries and lcd display damage.The mcu board and front housing assembly were replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-LEGACY ONE AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18963738
• MDR Text Key: 338443109
• Report Number: 3012307300-2024-01634
• 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
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1