MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC LVP PRIMARY ADMINISTRATION SET, DUAL INLET

Catalog Number SET001325

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

Customer reports the following: "nurse was giving an iv bolus of a medication, the tubing suddenly [burst], and the doctor got upset.Primed another tubing right away.The case got delayed a little bit because of it." the description indicates that the admin sets are leaking.This occurred during an active infusion and the case was delayed.No patient injury was reported.Reporting due to the referenced technical issue; no adverse effects or serious injuries were reported.More information is needed to complete the investigation.

Event Description

Drip chamber of both returned admin sets were found separated from admin set tubing due to failure of the glue bond.No signs of tubing damage from improper use.It was not described in the complaint that there were multiple admin sets where this had occurred.The complaint is considered to be confirmed as a result of the findings.The issue will continue to be monitored for any trends.

• Brand Name: LVP PRIMARY ADMINISTRATION SET, DUAL 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: 15764870
• MDR Text Key: 303631348
• Report Number: 3014732157-2022-00008
• 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,Followup
• Report Date: 02/17/2023

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: SET001325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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