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

Catalog Number SET0013

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

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The following has been reported: "primary admin set- unable to infused via downstream y- site of primary admin set that was running via gravity primary admin set had normal saline infusing without issue via gravity nurse attempted to attach second primary administration set to down stream y- site of first set and infuse ivig via the pump.Had check valve in place at the end of this primary set.Pump repeatedly alarmed downstream occlusion.Nurse then attached this primary set directly to the patient's access port and it infused without issue." delayed starting therapy but did not delay an active infusion.Reporting due to the referenced issue.No adverse effects were reported.More information is needed to complete the investigation.

• Brand Name: LVP PRIMARY ADMIN SET 2 INLET
• 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: 18288821
• MDR Text Key: 330462944
• Report Number: 3014732157-2023-00209
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: SET0013
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2023
• 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