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 during training by a fresenius kabi trainer: "pumps are alarming secondary occlusion alarm when trying syringes (medline 20 ml syringes syr12001) or secondary lines (bbraun secondary set v1921 40 in).I have swapped out 10 pumps and 10 sets and i tried different syringes and different secondary set, all have the same occlusion alarm.I have tried taking the set off and putting it back on, i have tried pulling the syringe barrel out and back to break the stiction.When i used my set i brought from home with a different lot- mine worked.The secondary set and the syringe both worked on my set that i brought with me." reporting due to the referenced issue.Occurred during training; 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: 18288541
• MDR Text Key: 330017092
• Report Number: 3014732157-2023-00198
• 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
• Device Lot Number: 3006073
• 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