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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 Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: event date unknown.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 information becomes available.
 
Event Description
It was reported that the device exhibited error code 4222 system failure.The fault occurred during testing and was not related to physical damage or abuse.There was unknown delay in therapy, no patient involvement and no patient harm.
 
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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 Key19214643
MDR Text Key341408592
Report Number3012307300-2024-03184
Device Sequence Number1
Product Code MEA
UDI-Device Identifier15019517099690
UDI-Public15019517099690
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0401-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2024
Date Manufacturer Received04/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/05/2019
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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