• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20129E
Device Problems Leak/Splash (1354); Reflux within Device (1522); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 08/03/2021
Event Type  malfunction  
Event Description
I changed my uvc double lumen fluids. I then got baby up for mom to hold. I noticed blood backing up into uvc line. I then noticed lipids on the mother's leg. I quickly realized the magic filter had come apart in the middle. I clamped the part of the filter that was still attached to the uvc and no blood was lost. I rehung fluids and attached them to uvc.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key12432301
MDR Text Key270155784
Report Number12432301
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 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20129E
Device Catalogue Number20129E
Device Lot NumberH37020129E1B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2021
Event Location Hospital
Date Report to Manufacturer09/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-