MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMP; PUMP, INFUSION

Model Number	6500
Medical Device Problem Codes	Device Alarm System (1012); Connection Problem (2900); 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 disposable, pump won't run" alarm.No patient injury reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection showed the device was in good condition.A review of the event history log (ehl) identified no disposable alarm.During the functional testing the reported issue was unable to be duplicated.The root cause of the issue was unable to be determined.As a preventative measure, the downstream sensor was replaced, and the upstream sensor re-calibrated.

• Brand Name: CADD LEGACY PLUS PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12839918
• Report Number: 3012307300-2021-11528
• Device Sequence Number: 19942109
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: Health Professional
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• 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