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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problems Device Alarm System (1012); Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported that the device had an error 41622.The error occurred during testing.There was no patient involvement and adverse event reported.
 
Manufacturer Narrative
B3 date of event unknown.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
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Brand Name
CADD-SOLIS AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key19198317
MDR Text Key341378672
Report Number3012307300-2024-03129
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586038778
UDI-Public10610586038778
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2110
Device Catalogue Number21-2111-0300-01
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/16/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2015
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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