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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 has error code 416222.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.Customer's complaint of error code 416222 was verified.The event log showed priming started, system fault 41,622 and power down on (b)(6) 2018.Service found a broken optical switch during testing.Service replaced the optic switch.Use testing was performed.The problem source is the optical switch.
 
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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 Key8052873
MDR Text Key126591539
Report Number3012307300-2018-08153
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586038808
UDI-Public10610586038808
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 12/18/2018
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 Number21-2112-0300-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Initial Date Manufacturer Received 10/09/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received11/19/2018
Supplement Dates FDA Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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