DeviceClearance

K170982

Substantially Equivalent

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

Applicant
Smiths Medical Ads, Inc.
Product code
MEA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MEA

product code MEA
Death
19
Malfunction
25,089
Total
25,108

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.