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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD®-SOLIS HPCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD® CADD®-SOLIS HPCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that this ambulatory infusion pump is delivering incorrect dosage.No adverse patient effects were reported.
 
Manufacturer Narrative
Evaluation results: one cadd solis pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint of delivering incorrect dosage was not verified.The event log contained no related evidence.The device passed the published specification of +/- 6%.Service trimmed the expulsor as a preventative measure to bring the device more into nominal range.Use testing was performed.The problem source is unknown.
 
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Brand Name
CADD® CADD®-SOLIS HPCA AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8021691
MDR Text Key125612560
Report Number3012307300-2018-08031
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/17/2019
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 No Information
Device Model Number2110
Device Catalogue Number21-2111-0100-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2019
Initial Date Manufacturer Received 10/03/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received11/15/2018
Supplement Dates FDA Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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