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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLUMAT MC AGILIA US; INFUSION PUMP SYSTEM
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VOLUMAT MC AGILIA US; INFUSION PUMP SYSTEM Back to Search Results
Catalog Number Z021135
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 01/11/2024
Event Type  malfunction  
Event Description
The following has been reported: 1.Details of patient event - the patient started with a saline hydration bag infusion.After that they received an ivig infusion which should have been set as an escalating rate procedure, then after that she gets another hydration bag infusion.During ivig the rate was accelerated at the hydration rate verses the escalating rate procedure in error.They are still investigating if this was pump related or user error related, however they do believe it was probably user error as the drug library seemed to be programed correctly.2.If medical intervention was required and if so what was that - patient became hypertensive, doctor ordered an oral steroid and antihistamine and patient was given additional fluids 3.Current status of the patient - she's fine, kept her a little bit longer, then she went home.Checked her the next day and she was still not feeling all better, but all her vitals were fine.Device serial number has not been able to be confirmed.Reporting as a conservative measure.More information is needed to complete the investigation.
 
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Brand Name
VOLUMAT MC AGILIA US
Type of Device
INFUSION PUMP SYSTEM
MDR Report Key18718178
MDR Text Key335529781
Report Number3004548776-2024-00037
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberZ021135
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2024
Distributor Facility Aware Date01/16/2024
Event Location Hospital
Date Report to Manufacturer02/15/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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