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

Model Number 2110

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd®-solis vip ambulatory infusion pump failed accuracy testing.There were no reported adverse effects.

Manufacturer Narrative

Device evaluation: one smiths medical cadd solis hpca pump was returned for analysis in a good condition.Event log history was performed, and no conclusive evidence existed in the event log to support the user's complaint.During analysis, the reported event regarding "failed accuracy test" was not replicated.Although one of three test runs fell slightly outside the production spec of +/-3% (+3.13%), all results were well within the published customer specification of +/-6%.The user did not specify if the pump was underinfusing or overinfusing.Service will trim the expulsor to try to bring the pump closer to nominal accuracy.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.

• Brand Name: CADD SOLIS HPCA PUMPS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8899024
• MDR Text Key: 154610125
• Report Number: 3012307300-2019-04102
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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: No Information
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1