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

Model Number	6500
Medical Device Problem Codes	Device Alarm System (1012); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd legacy plus pump, the pump exhibited "no message" alarm.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation: one cadd legacy plus pump was returned for analysis.Visual inspection performed, and product found with no external damage.Event history log review was performed and found evidence of reported problem.Visual inspection and functional testing were performed.The customer?s problem was unable to be duplicated.However, the reported problem was confirmed in the event log.According to the investigation, the reported issue was caused by "defective downstream occlusion sensor or upstream occlusion sensor that detects cassette connection.In additional problems with parts on the cassette side that come into contact with the pump sensor.As a preventative, the pump downstream sensor was replaced, and upstream sensor re-calibration.The problem source of the reported problem is unknown.

• Brand Name: CADD LEGACY PLUS PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12841237
• Report Number: 3012307300-2021-11534
• Device Sequence Number: 17163968
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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 Model Number: 6500
• Device Catalogue Number: 21-6500-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown