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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BECTON DICKINSON AND COMPANY BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2260-0500
Device Problems Display or Visual Feedback Problem (1184); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017)
Patient Problems Apnea (1720); Loss of consciousness (2418); Respiratory Failure (2484)
Event Date 03/15/2019
Event Type  Injury  
Event Description
Alaris pump immediately shut off after moving iv pole slightly.Pump alarms read channel error and shut off but continued to beep as iv lines were being switched over.Fentanyl gtt was removed and insulin gtt was loaded into pump.Shortly thereafter, pt became unresponsive and code was called.During code, it was noted that fentanyl infusion was taken off pump and erroneously infused off pump as roller clamp not applied to line resulting in respiratory depression and apnea.It was also noticed that the auto-lock mechanism on the iv tubing was not engaged when line was switched over to the pump just prior to code.
 
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Brand Name
BD ALARIS PUMP INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key8464409
MDR Text Key140441215
Report NumberMW5085307
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2260-0500
Device Catalogue Number2260-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age59 YR
Patient Weight62
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