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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 Insufficient Flow or Under Infusion (2182); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Event Description
It was reported that during pda administration in the delivery room as the patient was in labor, the pump did not support boluses.Per the reporter, there were no adverse patient effects.
 
Manufacturer Narrative
One device was returned for evaluation.Visual inspection revealed the entire device slightly worn and the battery compartment damaged.No problems were found in the event history log.Functional testing was unable to replicate the reported issue; the bolus button as well as the remote dose cord were working without a problem.The root cause was undetermined.No further action was taken.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 Key18934537
MDR Text Key338201320
Report Number3012307300-2024-01463
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeSZ
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 Number2110
Device Catalogue Number21-2111-0200-03
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 Manufactured04/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexFemale
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