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

Model Number 2110

Device Problems Volume Accuracy Problem (1675); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

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.H3: device not received by manufacturer.B3 is unknown.

Event Description

It was reported the device had a high volume delivery and a power button issue.There was unknown patient involvement.

Manufacturer Narrative

D9: (b)(6) 2024.One device was received for evaluation.Visual inspection found a scratched lens, worn uso seal, and a worn dso seal.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the customer's reported problem of 'over-delivery'; however, the reported problem of the power button's issue was duplicated.It was determined that the most probable cause was the power switch.The power switch was replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18610523
• MDR Text Key: 334729116
• Report Number: 3012307300-2024-00444
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 21-2111-0300-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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