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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON ALARIS MEDSYSTEM III IV INFUSION PUMP SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON ALARIS MEDSYSTEM III IV INFUSION PUMP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MEDSYSTEM III
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Death (1802)
Event Date 06/01/2020
Event Type  Death  
Event Description
Alaris mini-med infusion with epinephrine, amiodarone, and heparin infusing via three available channels. During patient transition to aircraft from er, the alaris iv pump spontaneously gave a "fault" error on all three running channels. Immediate attempt made to switch epinephrine infusion to stand-by second pump. Iv set with epinephrine from first pump placed into second alaris mini-med iv pump. The second pump immediately gave a "fault" error on channel a of the pump. The infusion was then transitioned to channel b and infusion restarted. The patient became bradycardic during the iv pump transition and troubleshooting. Patient subsequently became pulseless and cpr was initiated. Patient remained in cardiac arrest at the time of transfer to receiving facility where care was assumed and cpr continued. Fda safety report id# (b)(4).
 
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Brand NameALARIS MEDSYSTEM III IV INFUSION PUMP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON
franklin lakes NJ 07417
MDR Report Key10162319
MDR Text Key195538070
Report NumberMW5095018
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMEDSYSTEM III
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/16/2020 Patient Sequence Number: 1
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