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

Catalog Number SET003225

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

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The following has been reported: "primary line installed and infuses without issue.Secondary is kcl on a baxter secondary set.Pump alarms with continued upstream secondary occlusion alarms.It will not back prime and it will not infuse.Male/female adapter added to the secondary port to engage valve more thoroughly.This was unsuccessful.Pump completely shut down and rebooted with tubings in place.This was successful for approximately 10 minutes.The secondary occlusion alarm returned.Primary tubing exchanged, primed and put into service on the same pump.Infusion is now proceeding without additional alarms.Tubing collected and available to send to home office if needed." 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: 17420556
• MDR Text Key: 320039682
• Report Number: 3014732157-2023-00046
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: SET003225
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2023
• 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