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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM 2400, DISPLAY MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING

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BAXTER HEALTHCARE - ENGLEWOOD EM 2400, DISPLAY MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400D
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an exactamix compounder pumped a total parenteral nutrition bag that was a ¿lighter color of yellow¿. The customer mixed two 50 ml vials of ingredient into one to create the multi vitamin infusion. One vial was a clear ingredient and the other was yellow. The mix check report for these bags, showed a difference of less than 1% negative. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameEM 2400, DISPLAY MODULE
Type of DeviceSYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE - ENGLEWOOD
englewood CO
Manufacturer (Section G)
BAXTER HEALTHCARE - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6281560
MDR Text Key65897365
Report Number1416980-2017-00561
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2400D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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