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

Catalog Number Z019640

Device Problem Failure to Infuse (2340)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 03/09/2023

Event Type  Injury  

Event Description

The following has been reported: "patient presented a cra (cardiorespiratory arrest) after convulsion due to sudden pressure drop.The dobutamine pump which was at 15mcg/kg/min beeped the air bubble alarm, when it beeped the nursing technician entered the bedside to move the pump, but the pump was stuck (stopped working) and could not return.She called the nurse immediately, when the patient convulsed.On calling the doctor, the patient was found to be still.Only 1 cycle of cpr was performed, using 1 amp of adrenaline.It was not necessary to intubate the patient.When the pump stopped, it was verified that the medication bag was full, and there was no air in the line, but blood was returning in the central catheter, having occurred earlier in the morning.The medication was changed at 12 pm.The pump, which is on a different schedule, alarmed at 6:49 pm at the end of the infusion, and was reprogrammed at 6:49 pm.At 6:51 pm it alarmed air in the pump." reporting due to the referenced issue; no further information regarding the patient's condition has been communicated.More information is needed to complete the investigation.

Event Description

Device history record was reviewed and nothing was found related to the reported event.Device log was reviewed but datas were insufficient to confirm the reported event.The reported device was not returned to brézins for further investigation.However device log was provided and analyzed.Compared to complaint description, infusion has been effectively stopped by an air alarm (with visual and sound alerts.) actions on pump by medical staff have been done very quickly after this.Air alarm could have many causes linked to tubing set line, such as: air intake on bag side (from upstream side), and/or back flow from patient side (from downstream side).Note: settings of air parameters were unknown.Untempestive air alarm can be triggered if air setting is too low for the type of drug used, for example.Without the reported device to expertise, it is not possible to confirm a potential dysfunction.Furthermore dysfunction linked to air sensor will usually trigger permanent technical alarm which was not detected in the provided log.Based on the available information the root cause of the reported issue remains unclear.This complaint is considered as not confirmed.The trend is abnormal.The reported risk is lower compared to the estimated risk.For this issue as per our local procedure, we initiated no action.

• Brand Name: AGILIA VP MC BR
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• MDR Report Key: 16728473
• MDR Text Key: 313187701
• Report Number: 3004548776-2023-00094
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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?: Yes
• Device Operator: Other
• Device Catalogue Number: Z019640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Distributor Facility Aware Date: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening