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

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  malfunction  

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.

• 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
• Manufacturer (Section G): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047-8930 ; 8475502913
• MDR Report Key: 15592583
• MDR Text Key: 306281860
• Report Number: 3000240707-2022-00194
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: Z019730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention