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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PLUS PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD LEGACY PLUS PUMP; PUMP, INFUSION Back to Search Results
Model Number 6300
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3 event date, d4 udi, and g4 510k are unknown.No information has been provided to date.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.
 
Event Description
It was reported that the dose did not flow well.There was patient involvement, but no report of adverse event.
 
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Brand Name
CADD LEGACY PLUS PUMP
Type of Device
PUMP, INFUSION
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 Key18996639
MDR Text Key338940619
Report Number3012307300-2024-01881
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6300
Device Catalogue Number21-6300-09JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2024
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2017
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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