MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. INJECTOMAT AGILIA RC2; INFUSION PUMP SYSTEM

Catalog Number Z018097

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

The following has been reported: "on (b)(6), 2023, a 70-year-old male patient felt chest pain and was given intravenous solution infusion according to the doctor's advice.During the infusion, the pump was not installed alarmed and the failure was still after repeated debugging.The other pump was replaced immediately and the use was normal.Intended treatment disease or effect: coronary heart disease; intravenous pump drugs relieved the patient's chest pain.No concomitant medications/devices were used.The hospital thought that may lead to permanent damage to the body's function and structure." additional info obtained from the customer: sorry for that the customer described the question by mistake, the real question is that at the beginning of infusion, the syringe can't be monitored alarmed.Maybe the sensor was damaged.The debugging means that the customer tried to turn off the alarms and make the machine could be used normally.But they failed.They performed the debugging many times.The customer is not able to provide the log files & the defective part & repairing report for investigation, please be noted.Reporting due to the referenced issue.No additional issues or serious injuries to the patient were reported.More information is needed to complete the investigation.

Event Description

Device history record was reviewed, no issue has been found.Device log was not provided, therefore no review could be performed.The device injectomat agilia rc2 was not returned to our laboratory for analysis.Based on the information provided, the syringe cannot be monitored by the device which was on alarm.This is the normal behavior of the pump if a dysfunction trigger.No information about an error message has been provided.Without the affected sample, no investigation can be performed and no root cause can be determined.Due to the lack of information, the root cause cannot be identified.If further information are provided later on we will re-open the complaint and pursue the investigation.This complaint is considered as not confirmed.The trend is normal.The reported risk is lower compared to the estimated risk.For this issue as per our local procedure, we initiated no action.

• Brand Name: INJECTOMAT AGILIA RC2
• 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: 16840689
• MDR Text Key: 314397862
• Report Number: 3000240707-2023-00109
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z018097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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