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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS VIP PUMPS - 2120; PUMP, INFUSION
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ST PAUL CADD SOLIS VIP PUMPS - 2120; PUMP, INFUSION Back to Search Results
Catalog Number 21-2120-0103-01
Device Problems Inaccurate Delivery (2339); Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported the device needs calibrations.Under infusing.No patient injury/involvement reported.
 
Manufacturer Narrative
One sample was received for evaluation.Functional testing was unable to duplicate the customer's complaint, three separate delivery accuracy tests were performed.The root cause for this event was caused from bad expulsor.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.
 
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Brand Name
CADD SOLIS VIP PUMPS - 2120
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17216166
MDR Text Key318026202
Report Number3012307300-2023-06775
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number21-2120-0103-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2023
Was the Report Sent to FDA? No
Date Manufacturer Received06/12/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/16/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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