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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 LOAD CELL MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE CORPORATION EM2400 LOAD CELL MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400L
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the cable (load cell module) of an exacta mix automated compounding device was damaged.It was further reported the wires were exposed.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed which noted the device had a damaged cable; the outer sheath was damaged and no internal wires were exposed.The reported condition was verified as a damaged outer sheath.The cause of the damage could not be determined.The power cord will be replaced to resolve the condition.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EM2400 LOAD CELL MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11334364
MDR Text Key232172468
Report Number1416980-2021-00681
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/23/2021
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 Number2400L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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