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

Model Number 2110

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that the cadd prizm hpca pump had 10% accuracy test.Tested with other sets and still 10%.No reported adverse effects.

Manufacturer Narrative

Evaluation results: one cadd solis hpca pump was returned for investigation.The product problem reported by the customer could not be replicated.The flow rate was tested and found to be 28,98 ml/h.This value was within the tolerated range.The pump was determined to have passed final all tests.

• 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
• MDR Report Key: 8091495
• MDR Text Key: 128050811
• Report Number: 3012307300-2018-08428
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1