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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. CADD SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL MD, INC. CADD SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 21-2111
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A report was received that stated the pump alarmed "error code 44510".No patient injury or adverse event was reported.
 
Manufacturer Narrative
Device evaluation: the suspect device was received for evaluation.Inspection of the device once powered up confirmed error code 44510.Therefore, the circuit board was replaced.Following repair, the device passed all function and delivery testing.(b)(4).
 
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Brand Name
CADD SOLIS AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3966458
MDR Text Key4754724
Report Number2183502-2014-00358
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/30/2014
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 Health Professional
Device Model Number21-2111
Device Catalogue Number21-2111-010
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/05/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/30/2014
Event Location Hospital
Initial Date Manufacturer Received 04/29/2014
Initial Date FDA Received05/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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