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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
The reporter stated therapy was "started approx.9-20-19 and happened at least several times a week to daily.Over infusing 50-100 ml, but varies".They also noted the patient is a "pedi (4yo) and has to be on tpn 24 hrs or her blood sugars drop, this went on for approx.3 months.We switched tpn tubing to 0.2 filter high vol tubing (lipids separate) and since then is working fine".They also reported they "cannot give exact dates/ frequency of tubing over infusing".
 
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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 Key9470446
MDR Text Key170792670
Report Number3012307300-2019-07374
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027468
UDI-Public10610586027468
Combination Product (y/n)N
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 01/15/2020
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 Outcome(s) Congenital Anomaly;
Patient Age4 YR
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