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

Model Number 2110

Device Problem Device Alarm System (1012)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: event date unknown.One device was returned for evaluation.Visual inspection revealed a faulty downstream occlusion (dso) sensor and scratched lcd lens.No evidence was available to review in the event history log.Functional testing was able to replicate the reported issue.The most probable cause was determined to be a faulty dso sensor.The dso sensor was replaced.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 exhibited a cassette error.The issue was not related to physical damage or abuse.There was no delay of therapy, no patient involvement and no 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: 19130503
• MDR Text Key: 340466495
• Report Number: 3012307300-2024-02707
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: 10610586038808
• 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
• Report Date: 04/17/2024

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: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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