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 12/01/2022

Event Type  malfunction  

Event Description

Customer states the following: "primary occlusion - when backpriming not allowing them to backprime, no patient harm, but delay in treatment.If they change to another pump then this still happens.They had labeled it "primary occlusion".No tubing was clamped.They stated this has been happening just recently and are wondering if it is a tubing issue.No patient harm.No tubing saved, or pictures taken or pump info reported." occurred during an active infusion and a delay in therapy was experienced.4th of 4 reports as there were 4 instances communicated to fresenius kabi.The first 3 were reported on mdr#'s 3014732157-2022-00028, 3014732157-2022-00029 and 3014732157-2022-00030.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

Admin set not received from customer, not enough information to replicate issue.No additional information was provided (including lot identification).Due to the limited amount of information received, the event is not confirmed and the root cause remains unknown.Should additional information or samples be made available in the future, the complaint and investigation will be re-opened.

• 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: 16040672
• MDR Text Key: 308386475
• Report Number: 3014732157-2022-00031
• 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: 02/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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
• Date Manufacturer Received: 12/01/2022
• 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