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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 Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received that the cadd prizm hpca pump had cassette error.No reported adverse effects.
 
Manufacturer Narrative
One cadd solis hpca pump was returned for analysis.Visual inspection performed, and product found to be in good condition.Event log review was performed and found evidence of reported problem.The pump was visually inspected and was tested for any signs of malfunction and pressure failure.The customer's reported problem was not verified.The pump did not alarm when the cassette was attached to the pump during testing.Investigator found contaminate on the downstream sensor during the visual inspection.Service replaced the downstream sensor as a preventive measure.The root cause of the reported problem is unknown.
 
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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 lane north
minneapolis MN 55442
MDR Report Key8052877
MDR Text Key126592020
Report Number3012307300-2018-08154
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 12/20/2018
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 Manufacturer10/15/2018
Initial Date Manufacturer Received 10/09/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received11/21/2018
Supplement Dates FDA Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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