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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problems Device Alarm System (1012); Loss of Data (2903)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: one device was returned for evaluation.Visual inspection revealed no physical damage.Event history log review was not applicable.Functional testing was able to replicate and confirm the reported issue.The root cause was determined to be a defective internal battery.The main board was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
 
Event Description
It was reported that the device lost time and date several times and exhibited alarm error code 46011.The event occurred during preventive maintenance; there was no patient involvement and no patient harm.
 
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Brand Name
CADD-SOLIS AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18915139
MDR Text Key337796936
Report Number3012307300-2024-01423
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0402-14L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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