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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER EXACTAMIX EVA TPN BAGS

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BAXTER EXACTAMIX EVA TPN BAGS Back to Search Results
Lot Number 1175828
Device Problems Sensor (510); Device Alarm System (1012); Detachment Of Device Component (1104)
Patient Problems Air Embolism (1697); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Event Date 01/10/2017
Event Type  Injury  
Event Description

Reporter stated that she experienced a life threatening situation when the clamp of the baxter bag came off and allowed air to get into the sterile bag then eventually into her. As a result she suffered from air embolism and was transported to the emergency room by an ambulance. She also said that the tpn pump sensor is supposed to detect air coming into the system but it failed to do that. The reporter said she also experienced tachycardia, hypotension and sever chest pain. She was treated at the emergency room and released after 6 hours.

 
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Brand NameEXACTAMIX EVA TPN BAGS
Type of DeviceEXACTAMIX EVA TPN BAGS
Manufacturer (Section D)
BAXTER
MDR Report Key6629634
MDR Text Key77296376
Report NumberMW5070267
Device Sequence Number2
Product Code LHI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/08/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number1175828
OTHER Device ID NumberH938739
Was Device Available For Evaluation? No Answer Provided
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/08/2017 Patient Sequence Number: 1
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