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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 2426-0007
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/07/2021
Event Type  malfunction  
Event Description
Patient receives magnesium chloride 3 gram weekly through her port. Port was accessed and infusion hooked up with bd alaris pump infusion set tubing ref (b)(4). Pump was scanned and programmed, when i noticed that blood was coming back through the port access tubing and dripping onto the patient's shirt. The tubing from the pump was no longer connected, but the end of the tubing that connects to the clave was still connected. The tubing had snapped/broken off right at the connector. It was a clean snap like it was defective tubing. Fortunately, it was noticed right away so the patient did not keep bleeding through the connector, but it did require getting another medication and tubing.
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key12480523
MDR Text Key271670379
Report Number12480523
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 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number21059024
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2021
Event Location No Information
Date Report to Manufacturer09/16/2021
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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