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

Model Number 6500

Device Problem No Flow (2991)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).Occupation: product complaint analyst.

Event Description

Information was received indicating that a smiths medical cadd legacy plus pump did not infuse an epoch-r medication.The patient reported that the pump was never turned off at any point.There was no patient injury.

• Brand Name: CADD LEGACY PLUS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11619918
• MDR Text Key: 243966467
• Report Number: 3012307300-2021-02869
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

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 Operator: No Information
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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