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

Model Number 2110

Device Problems Mechanical Problem (1384); Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3 unknown, d3, g1, and g2 email is: (b)(6).

Event Description

It was reported that the pump did not work properly and failed calibration.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

Other text: one device was returned for analysis.Visual inspection showed the pump was in good condition.The tamper seal was removed.Review of the event history log (ehl) showed upstream occlusion alarms.A functional and accuracy tests were performed and the reported issue was not duplicated, however upstream occlusion alarm messages were found in the device's event history logs.It was determined that the cause was due to the upstream occlusion sensor.As a result, the upstream occlusion sensor was replaced.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.B3 updated, d3, g1, and g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18287635
• MDR Text Key: 330128676
• Report Number: 3012307300-2023-10960
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K170982
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1