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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 Insufficient Information (4580)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported that the device would sporadically not recognize the cassette.There was unknown patient involvement and unknown patient harm.
 
Manufacturer Narrative
Event date unknown.Initial reporter phone (b)(6).One device was returned for evaluation.Visual inspection revealed the display lens broken.Event history log review was not required.Functional testing was able to replicate the reported issue; the occlusion pressure was too low (14.5psi).The root cause was determined to be the downstream occlusion (dso) sensor.The dso sensor was to be re-calibrated/replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
 
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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 Key19139942
MDR Text Key340807156
Report Number3012307300-2024-02759
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeGM
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 04/18/2024
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 Number21-2111-0200-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2024
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2011
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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