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

Model Number 2110

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that this ambulatory infusion pump is delivering incorrect dosage.No adverse patient effects were reported.

Manufacturer Narrative

One cadd solis pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint of delivering incorrect dosage was not verified.The event log contained no related evidence.The device passed the published specification of +/- 6%.Service trimmed the expulsor as a preventative measure to bring the device more into nominal range.Use testing was performed.The problem source is unknown.

• Brand Name: CADD® CADD®-SOLIS HPCA 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: 8021698
• MDR Text Key: 125612613
• Report Number: 3012307300-2018-08032
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: 21-2111-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1