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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 Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
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 the reported issue; error code 41622 was displayed on the pump after power up.The root cause was determined to be the cam sensor.The cam sensor 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 exhibited error code 41622.The product fault 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 Key19093691
MDR Text Key340681624
Report Number3012307300-2024-02485
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2024
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 Number2110
Device Catalogue Number21-2111-0300-50
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2017
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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