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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 6300
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Manufacturer Narrative
B3: unknown.One device was received for evaluation.Visual inspection found the device to be in good condition.Functional testing was unable to duplicate the issue; however, the device was instead found to be delivering too high.To address the issue the expulsor was trimmed.The service history review identified no indication that the complaint was related to a service of the device within the review period.
 
Event Description
It was reported the device's flow rate is too low.There was no patient involvement.
 
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Brand Name
CADD LEGACY PCA 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 ln n
minneapolis, MN 55442
2247062300
MDR Report Key19112549
MDR Text Key340710464
Report Number3012307300-2024-02594
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586019357
UDI-Public10610586019357
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K982839
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6300
Device Catalogue Number21-6300-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
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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