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

Model Number 2110

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Event date unknown.One device was returned for evaluation.Visual inspection revealed no physical damage.Event history log was reviewed and functional testing performed; the reported issue could not be confirmed or replicated; the device passed all testing.The root cause was undetermined.Preventative maintenance was performed.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 dispensing volume was low; it delivered 9.16ml when it was set to deliver 10ml.It is unknown if there was patient involvement and unknown if there were any adverse patient effects.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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: 18860683
• MDR Text Key: 337292012
• Report Number: 3012307300-2024-01198
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: 10610586041037
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111275
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 21-2111-0400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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