MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd cassette reservoir could not flow.No adverse effects were reported.

Manufacturer Narrative

Additional information was received about the event: the message only popped up for a moment and that "upward thrust" next to a small short beep.The cassette seemed to continue to run, but after about 3 minutes another beep and briefly the same message.This has repeated itself a few times even after all the normal actions they perform with the cassette if there is an error message.Ultimately, another cassette was attached and the message no longer occurred.The cassette contained an antibiotic.

Manufacturer Narrative

The device was received for evaluation.Visual and functional testing were performed and the reported issue was not confirmed.Visual inspection did not reveal any damage.During functional testing, the sample was filled and primed per testing protocol and the reported issue could not be duplicated.Manufacturing controls are in place to help prevent occurrence of the reported issue.A manufacturing device history review (dhr) was not performed because the lot number was not provided.The root cause for the reported issue could not be determined.Complaint trends will continue to be monitored.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11343534
• MDR Text Key: 232381757
• Report Number: 3012307300-2021-01329
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1