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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. AGILIA VP MC WIFI GB; INFUSION PUMP SYSTEM

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FRESENIUS VIAL S.A.S. AGILIA VP MC WIFI GB; INFUSION PUMP SYSTEM Back to Search Results
Catalog Number Z019730
Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problems Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2022
Event Type  Injury  
Event Description
Customer reports the following: "complaint report received stating that vp mc wifi was infusing to a paediatric patient and nurse noted extravasation injury.Pump was taken out of use and sent to engineering for review.Engineering reviewed the device and event log and deemed this a 'clinical error' as the pressure limit had been increased from 150mmhg (default setting) to 600mmhg.There were also multiple occlusion errors observed on the device.Harm as caused to the patient." reporting due to the referenced incident.More information is needed to complete the investigation.
 
Event Description
Device history record was reviewed but nothing linked to the reported event was observed.Device log history was reviewed on the reported date: 15 august.On 15 august at 12:27, infusion is started @ 33 ml/h with a vtbi of 100 ml.At 13:20, a first alarm (not an error) of downstream occlusion is triggered.Pressure limit set @ 400 mmhg at starting, and increased @ 600 mmhg after 2 occlusions alarms at 13:32.During all the afternoon, a total of 10 downstream occlusion alarms are recorded.Pressure limit is decreased at 300 mmhg at 15:17.End of infusion alert (vtbi of 100 + 100 ml reached) is done at 20:47.After, infusion continues during all the night with same flow rate and events of regular occlusions.Note: after each occlusion alarm, a re-start of infusion is mandatory on the pump by user.Therefore, history data could not confirm events described in complaint because the pump has triggered a lot of occlusion alarms to alert an overpressure on downstream side and cannot confirm events described in complaint.The reported device was returned to france for further investigation.The visual check of the pump was compliant.Several tests: pressure accuracy - occlusion alarm accuracy- accuracy flow rate measurement : were performed.All results were compliant with ifu values specifications.The reported event could not be reproduced.No cause can be identified compared to the complaint because all performance tests linked to complaint are compliant compared to our ifu specifications and there's no dysfunction of the pump.This complaint is considered as not valid.For this issue as per our local procedure, we initiated no action.
 
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Brand Name
AGILIA VP MC WIFI GB
Type of Device
INFUSION PUMP SYSTEM
Manufacturer (Section D)
FRESENIUS VIAL S.A.S.
le grand chemin
brezins, 38590
FR  38590
MDR Report Key15592582
MDR Text Key301630501
Report Number3004548776-2022-00196
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberZ019730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2022
Distributor Facility Aware Date09/14/2022
Event Location Hospital
Date Report to Manufacturer12/22/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/12/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/22/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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