MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC LVP PRIMARY ADMIN SET 2 INLET & YSITE; ADMINISTRATION SET

Catalog Number SET0032

Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

The following has been reported: "during go live at newport news nurse reported: "we had a pump programmed with an iron infusion.It was set up to infuse to empty; but it didn't.Then it pulled enough air to produce an air-in-line alarm instead of converting back to primary".The secondary did not infuse to empty, even though it was programmed to.So the nurse reprogrammed to catch the remaining secondary and then convert to primary.The pump continued to draw from secondary and pulled air into the cassette.No patient harm." this issue delayed an active infusion, but it was completed.Reporting due to the referenced technical issue.No adverse effects to the patient were reported.More information is needed to complete the investigation.

• Brand Name: LVP PRIMARY ADMIN SET 2 INLET & YSITE
• Type of Device: ADMINISTRATION SET
• 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 60047-8930 ; 8475502913
• MDR Report Key: 18207650
• MDR Text Key: 328983709
• Report Number: 3014732157-2023-00191
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2023

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 Operator: Other
• Device Catalogue Number: SET0032
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1