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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER BAXTER BIFURCATED TUBING
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BAXTER BAXTER BIFURCATED TUBING Back to Search Results
Lot Number GR336024
Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)
Patient Problems Death (1802); Hyperglycemia (1905)
Event Date 01/22/2017
Event Type  Death  
Event Description
Tpn bag noted to be empty with ivf infusing at correct rate through the iv pump.Infant received 24 hour volume in 12 hour period.Md notified.To bedside.Suspected seizures.This report lists carefusion smartsite low sorbing infusion set 16127819, 12/29/2019, (b)(4).
 
Event Description
Additional information received from reporter on 02/08/2017 for report mw5067639: tpn bag noted to be empty with ivf infusing at correct rate through the iv pump.Infant received 24 hour volume irl 12 hour period.Md notified.To bedside.Suspected seizures.This report lists baxter bifurcated add on transfer set, lot (10) gr336024.
 
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Brand Name
BAXTER BIFURCATED TUBING
Type of Device
BIFURCATED TUBING
Manufacturer (Section D)
BAXTER
deerfield IL 60015
MDR Report Key6300258
MDR Text Key66479223
Report NumberMW5067639
Device Sequence Number0
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/02/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberGR336024
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
BAXTER BIFURCATED ADD ON TRANSFER SET, ; FEEL AT THIS TIME THAT IT POTENTIALLY CONTRIBUTED ; LOT (10) GR336024 WAS ALSO USED, HOWEVER DO NOT ; TO THE EVENT.
Patient Outcome(s) Death;
Patient Age7 DA
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