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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 NameBAXTER BIFURCATED TUBING
Type of DeviceBIFURCATED 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
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
Device Lot NumberGR336024
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? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/02/2017 Patient Sequence Number: 1
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.
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