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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7349-24
Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation in progress.
 
Event Description
It was reported that the cadd administration set had issues with flow.The pump that was attached to the administration set produced an occlusion alarm.The anesthesia technician tried to normally prime, and gravity prime, the unit without success.The occlusion problem resulted in under delivery of the epidural.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11021841
MDR Text Key222001644
Report Number3012307300-2020-12484
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517184235
UDI-Public15019517184235
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7349-24
Device Catalogue Number21-7349-24
Device Lot Number4033588
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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