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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION
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CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problem Insufficient Information (3190)
Patient Problem Arrhythmia (1721)
Event Date 05/09/2022
Event Type  Injury  
Event Description
It was reported that the patient received an over infusion of levophed due to a free flow event.The hospital indicated the event occurred while the infusion was being prepared and before the tubing was placed into the pump.However following the event, the patient's systolic blood pressure was greater than 200mmhg with noted ventricular arrhythmia.The patient received an infusion of esmolol to lower heart rate and blood pressure and required prolonged transfer to the critical care unit.
 
Manufacturer Narrative
The information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.
 
Event Description
It was reported that the patient received an over infusion of levophed due to a free flow event.The hospital indicated the event occurred while the infusion was being prepared and before the tubing was placed into the pump.However following the event, the patient's systolic blood pressure was greater than 200mmhg with noted ventricular arrhythmia.The patient received an infusion of esmolol to lower heart rate and blood pressure and required prolonged transfer to the critical care unit.
 
Manufacturer Narrative
Additional information: relevant tests/laboratory data, medical device serial #, device manufacture date, imdrf annex b code and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
 
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Brand Name
ALARIS SYSTEM
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key14770720
MDR Text Key294483673
Report Number2016493-2022-155297
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public(01)10885403810015
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100 ALARIS LVP MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8015
Patient Outcome(s) Required Intervention;
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