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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 11532269
Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2023
Event Type  malfunction  
Event Description
During durvalumab infusion, patient's wife noticed liquid on the floor.Losarb tubing had a small puncture in the tubing, and liquid was leaking from the tubing and onto the floor.Infusion immediately paused.Tubing patched with gauze and coban.Infusion then completed in a few minutes after the patch job.Patient did not receive the full dose of durvalumab since some had leaked onto the floor.Unsure how much fluid leaked and how much was infused into the patient.Dr.Made aware and chemo pharmacy made aware.Tubing then discarded.
 
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Brand Name
ALARIS, SMARTSITE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key16768154
MDR Text Key313567397
Report Number16768154
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 04/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number11532269
Device Catalogue Number11532269
Device Lot Number(10) 22105087
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2023
Event Location Hospital
Date Report to Manufacturer04/19/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24090 DA
Patient SexMale
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