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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2021
Event Type  malfunction  
Event Description
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 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 clamps were released and the infusion was dripping very slowly. The nurses attempted to infuse a separate new iv bag and the infusion was flowing through with no issues. Therefore, there were no issues with the alaris pump. The nurses had to continuously infuse the rest of the erbitux by pressing the infuse button over and over again. The pump kept stating an occlusion in the tubing line. The last few cc's of the infusion took a longer time to infuse than expected. Therefore, the tubing is suspected to be faulty. Lot # 20116927, ref# (b)(4). Fda safety report id # (b)(4).
 
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Brand NameBD ALARIS PUMP INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
MDR Report Key11581744
MDR Text Key243137473
Report NumberMW5100337
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 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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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