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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXA CORPORATION BAXA EM2400 COMPOUNDER

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BAXA CORPORATION BAXA EM2400 COMPOUNDER Back to Search Results
Event Type  Malfunction  
Event Description

The (b) (6) pharmacy department uses a baxa em2400 compounder to make tpn's and other admixtures. Recently, the compounder was infected with a virus. The virus has been contained on the em2400 compounder. It is unknown what effect this virus should have on the operating of the software. (b) (6) information systems department together with the pharmacy has requested that baxa provide a microsoft security patch to prevent this infection from occurring again. Baxa is unwilling to allow these patches to be applied to the baxa em2400. Instead baxa has recommend that we place a router with the functionality for a firewall between the compounder and the network (b) (4) as protection. In a single case, this may be a possible solution. (b) (6)'s manager indicates that if this was the routine solution, (b) (6) would then have to procure and maintain over 1000 routers institution wide. That approach is not sustainable by (b) (6) nor the marketplace. I am interested to hear about fda's requirement for medical devices to have security patches that protect the device from contamination.

 
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Brand NameBAXA EM2400 COMPOUNDER
Type of DeviceBAXA EM2400 COMPOUNDER
Manufacturer (Section D)
BAXA CORPORATION
14445 grasslands dr.
englewood CO 80112
MDR Report Key1621627
Report NumberMW5014956
Device Sequence Number1
Product CodeNEP
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 02/26/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

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