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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE - ROUND LAKE EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400M
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This report summarizes 3 malfunction events.It was reported that precipitation occurred during compounding using three (3) exactamix compounding devices.For the first event, the reporter stated that there were fibers found in the final tpn bags after compounding using an exactamix compounding device.Troubleshooting was performed with the customer.The customer submitted configuration reports to be reviewed to determine if any of the ingredients would create the fibers.No issues were identified that would cause fibers in the bags.The customer was instructed to change the inlet and valve set.After changing the bags, the issue was resolved.For the second event, the reporter stated that multiple vitamin ingredient (mvi) was flowing into the sodium phosphorus line, leading to precipitation.The customer replaced the valve set.Troubleshooting was performed with the customer.The customer submitted configuration reports to be reviewed.No issues were identified during review of the configuration reports.For the third event, it was reported that precipitation occurred during compounding using an exactamix compounding device.The reporter stated that pediatric multiple vitamin ingredient (mvi) was flowing into the sodium phosphorus line, leading to precipitation.It was not specified if any troubleshooting steps were performed or what steps were taken to resolve the issue.There was no patient involvement for any of the events.No additional information is available.
 
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Brand Name
EM 2400, MAIN MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE - ROUND LAKE
round lake IL
Manufacturer (Section G)
BAXTER HEALTHCARE - ROUND LAKE
25212 w. illinois route 120
round lake IL 60073
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8831544
MDR Text Key152530488
Report Number1416980-2019-04046
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2400M
Date Manufacturer Received06/30/2019
Type of Device Usage N
Patient Sequence Number1
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