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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS VIP PUMP; PUMP, INFUSION
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ST PAUL CADD SOLIS VIP PUMP; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problems No Audible Alarm (1019); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2021
Event Type  malfunction  
Event Description
Information was received indicating that a new infusion of tpn with a smiths medical cadd solis vip pump was started, then it was noticed that there was blood in the tube and the pump did not deliver anything.It was also reported that the pump did not alarm.The clamp was closed and then the pump was closed.The cadd administration set was changed and then the pump worked well.There was no patient injury.
 
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Brand Name
CADD SOLIS VIP PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11361366
MDR Text Key233020825
Report Number3012307300-2021-01430
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2021
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 Number2120
Device Catalogue Number21-2120-0103-14
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2021
Initial Date FDA Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2017
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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