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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7381-24
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Injury (2348)
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical cadd administration sets, over-infusion was noticed mainly in taper mode (tpn).It was reported that "patient was possibly injured due to the over infusion".No additional adverse effects were reported.
 
Manufacturer Narrative
Additional information was received indicating that the over-infusion began approximately 20-sep-2019 and continued for about three (3) months.Per reporter, the issue continued "at least several times a week to daily." it was reported that the amount of over-infusion varied but was approximately 50-100 ml.Per reporter, after switching the "tubing to 0.2 filter high volume tubing (lipids separate)" it is "working fine.".
 
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Brand Name
CADD ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9470447
MDR Text Key170891203
Report Number3012307300-2019-07375
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027468
UDI-Public10610586027468
Combination Product (y/n)N
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number21-7381-24
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age4 YR
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