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

Catalog Number 21-2111-0300-01

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that a cadd®-solis ambulatory infusion pump did not have accurate delivery.No report of any patient involvement.

Manufacturer Narrative

One pump was returned for analysis in used condition.Visual inspection of the pump showed that the pump was in good physical condition.Functional testing included accuracy testing.The delivery accuracy tests found the pump to be well within the published specification of +/-6%.Based on the evidence, the complaint was unable to be confirmed.

• Brand Name: CADD® CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7885444
• MDR Text Key: 120556094
• Report Number: 3012307300-2018-03593
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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: Lay User/Patient
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1