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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. AGILIA SP MC WIFI CA; INFUSION PUMP SYSTEM
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FRESENIUS VIAL S.A.S. AGILIA SP MC WIFI CA; INFUSION PUMP SYSTEM Back to Search Results
Catalog Number Z018734
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 02/14/2024
Event Type  Injury  
Event Description
The following has been reported: syringe pump was being used to infused norepinephrine for an icu patient.At 1603, bedside nurse learner titrated norepi down as map 91.At 1604, bedside nurse noted syringe pump no longer infusing, patients bp extremely elevated (sbp 280's) and then pump commenced alarming with error 22-0002 and then error 22-0004.Norepi switched to different pump immediately with this alarm, but patient required additional medication to bring down bp (propofol bolus 40mg x2).Based on bp response, it seems suspicious that patient likely received unsolicited bolus of medication from the pump.Reporting as a conservative measure.More information is needed to complete the investigation.
 
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Brand Name
AGILIA SP MC WIFI CA
Type of Device
INFUSION PUMP SYSTEM
Manufacturer (Section D)
FRESENIUS VIAL S.A.S.
le grand chemin
brezins, 38590
FR  38590
MDR Report Key18879146
MDR Text Key337410578
Report Number3004548776-2024-00067
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberZ018734
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2024
Distributor Facility Aware Date02/14/2024
Event Location Hospital
Date Report to Manufacturer03/11/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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