MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMPS 6500; PUMP, INFUSION

Model Number 21-6500-51

Device Problems Device Alarm System (1012); Pressure Problem (3012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the pump alarmed high pressure.No adverse patient effects were reported by the customer".

Manufacturer Narrative

One device was returned for investigation.The device was functionally tested and passed all tests.The reported problem could not be duplicated.However, the event history logs found high pressure messaged.Preventative action was taken to replace the downstream sensor.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: CADD LEGACY PLUS PUMPS 6500
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16875350
• MDR Text Key: 314619652
• Report Number: 3012307300-2023-05136
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-6500-51
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1