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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 10794983
Device Problems Break (1069); Failure to Infuse (2340)
Patient Problem Insufficient Information (4580)
Event Date 01/19/2021
Event Type  malfunction  
Event Description
Patient in critical condition started to show rapid deterioration, multiple interventions were being done to stabilize patient and upon going to connect epi drip, it was noted that the bi-extension set which multiple infusions (norepi, tacro, milrinone) were infusing had broken off from the lumen. The luer lock piece was still attached, however, the plastic part was broken and therefore noted that these drugs were not infusing to the patient. It is unknown exactly how long these drugs were not infusing as the area did not seem wet. Tubing connections changes promptly, lumen flushed well with no issues, drugs re-started and epi drip started as well. Manufacturer response for y-site connection tubing, bd extention set smallbore tubing (per site reporter): they are following up on this event, and have entered a report of this event to fda as well. They are in the process of investigating.
 
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Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key11445290
MDR Text Key238666278
Report Number11445290
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 Risk Manager
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10794983
Device Lot Number(10) 20095142
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2021
Event Location Hospital
Date Report to Manufacturer03/09/2021
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

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