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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 pt injury or adverse event was reported.
 
Manufacturer Narrative
The suspect device was received for eval.Review of the device history record and testing found error code 44510.Therefore, the circuit board was replaced.Following repair, the device passed all function and delivery testing.
 
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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 Key3814827
MDR Text Key20109285
Report Number2183502-2014-00230
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 User Facility,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/17/2014
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
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/12/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2014
Device Age2 YR
Event Location Hospital
Initial Date Manufacturer Received 03/21/2014
Initial Date FDA Received04/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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