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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 24301-0007T
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 04/12/2021
Event Type  malfunction  
Event Description
We came across an issue on a tubing set. The patient was receiving 1050 mg of erbitux, which was 525 ml over 60 minutes. The iv bag was infusing successfully with no issues until it came down to the last 20cc. The infusion was stopped by the alaris pump and read that there was an occlusion in the tubing. The nurse inspected the tubing and the iv bag and did not witness any occlusion. The nurse attempted to infuse a separate new iv bag through the same alaris pump line, and the infusion was flowing through with no issues. The nurse also tried to infuse the defective erbitux iv bag through a different alaris pump line, but it still was not flowing. Therefore, there were no issues with the alaris pump. This is currently the second time it's occurring with the same patient. Our corrective action plan this time was to change the tubing, and the infusion was administered successfully. Lot # 20116927 ref# 24301-0007t. Fda safety report id # (b)(4).
 
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Brand NameBD ALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC
MDR Report Key11669555
MDR Text Key245820771
Report NumberMW5100780
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24301-0007T
Device Lot Number20116927
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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