MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX INFUSION SYSTEM; INFUSION MANAGEMENT SYSTEM (IMS)

Model Number	030-0027-06
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: a medication error involving vancomycin administration on the ivenix pump.The correct dose was selected, but the selected concentration was incorrect and this resulted in an infusion rate error.There was no patient harm.Additonal information: "only infused 150 ml of the 250 ml bag.Infused at 150 ml/hr instead of 250 ml/hr." unknown if an active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
After review of all information, it was determined that the infusion rate error (incorrect concentration) was not due to any malfunction of the ivenix management system.The user entered the incorrect concentration that resulted in an incorrect rate.The pump sorts admixtures by concentration only, if there are multiple admixtures with the same concentration the customer request is that they are additionally sorted by drug amount.The request is being evaluated by fresenius kabi.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: INFUSION MANAGEMENT SYSTEM (IMS)
• Manufacturer (Section D): FRESENIUS KABI USA LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): FRESENIUS KABI USA LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502913
• MDR Report Key: 20507453
• Report Number: 3014732157-2024-00760
• Device Sequence Number: 20985905
• Product Code: PHC
• UDI-Device Identifier: 00811505030443
• UDI-Public: 00811505030443
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 030-0027-06
• Device Catalogue Number: 030-0027-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown