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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION Back to Search Results
Model Number 21-2120-0105-01
Device Problems Battery Problem (2885); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
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 a pump that shut off saying the batteries were dead but new ones had just put in the day before.No patient injury reported.
 
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Brand Name
CADD SOLIS VIP AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16887755
MDR Text Key314777235
Report Number3012307300-2023-05307
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517150001
UDI-Public15019517150001
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-2120-0105-01
Device Catalogue Number21-2120-0105-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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