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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7052-24
Device Problems Partial Blockage (1065); Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Information was received indicating that a smiths medical pump was alarming with occlusion.This issue does not happen with every extension line but it does happen with one specifically.There were no reported adverse events.
 
Event Description
Device not returned.Video submitted for evaluation.
 
Manufacturer Narrative
Investigation completed on a smiths medical ambulatory infusion pumps|cadd extension sets.No product was returned.A video was submitted on the malfunction.The extension set causing occlusion alarm was confirmed.The engineering production was reviewed with no discrepancies and the production passed testing 100% prior to release of product the cause is believed to be excess solvent was applied in the solvent bonds.Production personnel was trained on 30-jan-2020 on pm-417 rev.104 in order to reinforce the solvent application.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10931424
MDR Text Key219116707
Report Number3012307300-2020-11980
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586020346
UDI-Public10610586020346
Combination Product (y/n)N
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7052-24
Device Lot Number4016614
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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