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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD TPN SOFTWARE; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE - ENGLEWOOD TPN SOFTWARE; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 83000193
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a label printed for an order using abacus software had magnesium when there was not supposed to be magnesium in the bag.The bag was sent to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
TPN SOFTWARE
Type of Device
SYSTEM/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 Key7642338
MDR Text Key112567969
Report Number1416980-2018-03906
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 Other
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number83000193
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/01/2018
Initial Date FDA Received06/27/2018
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 N
Patient Sequence Number1
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