MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 PUMPS - 6400; PUMP, INFUSION

Model Number 21-6400-51

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

D5: operator of device was not provided and is unknown.E4: initial reporter also sent report to fda was not provided and is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.The device was returned and found all intact.There was no evidence of error message on the event history log (ehl).Visual and function testing was performed.The technician ran three accuracy tests, the pump was found to be within manufacturing specifications.The reported problem was not duplicated.An expulsor assembly was replaced to address the issue.No actions for the current issue.The root cause of the reported issue was unable to be determined.

Event Description

It was reported that a pump failed for delivery accuracy during testing ( -11.45%).

• Brand Name: CADD LEGACY 1 PUMPS - 6400
• 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: 16763181
• MDR Text Key: 313523156
• Report Number: 3012307300-2023-04257
• 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: 04/18/2023

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
• Device Model Number: 21-6400-51
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1