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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 Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
One cadd solis pump was returned for analysis.The device was visually inspected and found to be in good condition.The event log was unable to be downloaded.Service replaced the casssette latch/lock assembly.Customer's complaint was not verified.The problem source is unknown.
 
Event Description
Information was received that the cadd prizm hpca pump had defective cassette assembly.No reported adverse effects.
 
Event Description
Additional information indicated that there was no patient involvement.
 
Manufacturer Narrative
One cadd solis hpca pump was returned for analysis in good condition.The pump was visually inspected to confirm the reported claim of a defective cassette assembly.The customer did not return the cassette for evaluation the issue.Therefore; the "defective cassette assembly" issue was unable to be determined.It's recommend that the cassette latch/lock assembly to be replaced as a preventive measure.
 
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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 Key8157055
MDR Text Key130266727
Report Number3012307300-2018-08538
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,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
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 Manufacturer11/14/2018
Date Manufacturer Received06/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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