MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problems Device Alarm System (1012); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.Visual inspection revealed the device in good condition; just the display glass was scratched.Event history log review was not applicable.Functional testing was able to replicate the reported issue; the pump was found to be working properly and is activated within specification.The stated problem with the battery could not be confirmed because the customer did not provide the battery.The issue of the start button defective was confirmed as the device would only start if the on/off button was pressed more firmly.The root cause was unknown.Actions to be taken were pending response from the customer.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

Event Description

It was reported that the device akku was defective, the device always gave an occlusion alarm, and the start button was defective.There was unknown patient involvement and unknown patient harm.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19101327
• MDR Text Key: 340686162
• Report Number: 3012307300-2024-02559
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

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: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1