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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD-SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: event date unknown.One device was returned for evaluation.Visual inspection revealed no physical damage.No problems were found in the event history log.Functional testing was able to replicate and confirm the reported issue; the flow rate was slightly too low.The root cause was unknown.Preventive maintenance was to be performed.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 delivery rate was too low, below 117.5ml/hr.It was unknown if there was patient involvement or patient harm.
 
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Brand Name
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION
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 Key18934290
MDR Text Key338250812
Report Number3012307300-2024-01459
Device Sequence Number1
Product Code FRN
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 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2120
Device Catalogue Number21-2120-0105-03L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2024
Date Manufacturer Received02/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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