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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMP; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problem Inaccurate Flow Rate (1249)
Patient Problems No Patient Involvement (2645); Not Applicable (3189)
Event Type  malfunction  
Event Description
Information received indicating that a smiths medical cadd solis vip pump failed flow test.No adverse effects reported,.
 
Event Description
Additional information was received indicating that the issue occurred during "in house testing/inspection" process and there was no patient involvement.
 
Manufacturer Narrative
Other, other text: h3: one cadd solis vip pump was received in good physical condition.The event history log was reviewed and there was no evidence of the reported issue.A pump accuracy test/report was performed and the reported issue was unable to be confirmed.The pump was operating as per manufacturing specification.There was no fault found with the returned pump.
 
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Brand Name
CADD SOLIS VIP PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10268183
MDR Text Key198677229
Report Number3012307300-2020-07244
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517126587
UDI-Public15019517126587
Combination Product (y/n)N
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 10/20/2020
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 Number2120
Device Catalogue Number21-2120-0104-01
Was Device Available for Evaluation? No
Date Returned to Manufacturer07/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/02/2020
Initial Date FDA Received07/13/2020
Supplement Dates Manufacturer Received07/14/2020
09/24/2020
Supplement Dates FDA Received08/10/2020
10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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