MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION

Model Number 2120

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that smiths medical cad solis pump reads key stuck.No patient involvement.

Manufacturer Narrative

Other, other text: device evaluation: one cadd solis vip pump was returned for analysis.Visual inspection performed, and product found to be in a good condition.Event history log review was performed and found evidence of reported problem.Visual inspection, functional testing, and keypad testing were performed.Investigation unable to duplicate customer reported problem and error did not recur.Service replaced the pump keypad as a precaution and perform full pm test and functional test which passed.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10103955
• MDR Text Key: 193032571
• Report Number: 3012307300-2020-05352
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1