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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. AS LVP 20D 3SS CV BV; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. AS LVP 20D 3SS CV BV; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 11522558
Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
Situation: patient has had multiple events where the lipid tubing fails to drip background: patient is receiving total parenteral nutrition (tpn)/lipids.The lipids go through the new special filtered tubing.At least 6 times for this patient, the tubing on the lipids continue to beep off occluded even though the tpn running through the same lumen does not beep off.After trouble shooting, we find out there is no occlusion.Action: we have then noticed that the lipids will not even continue to drip and ultimately new tubing has to be primed with the lipids and restart them again.Recommendation: looking into seeing if there is a defect in the tubing that is causing it to malfunction.The device was disposed of by rn.There was no detectable harm in this event.
 
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Brand Name
AS LVP 20D 3SS CV BV
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key11670209
MDR Text Key245587525
Report Number11670209
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number11522558
Device Catalogue Number11522558
Device Lot NumberUNSURE, (10) 20116053 CURRENT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2021
Event Location Hospital
Date Report to Manufacturer04/14/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age7300 DA
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