MAUDE Adverse Event Report: ICU MEDICAL, INC. PRIMARY PLUM SET IV TUBING WITH FILTER, 1.2 MICRO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 12539-05

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Tpn was started on a patient.Staff later noticed leaking from filter on iv tubing.Replaced iv tubing and leak at filter happened again.Both of the tubing sets were from the same lot number.Replaced with tubing from new lot and no leak occurred.Fda safety report id# (b)(4).

• Brand Name: PRIMARY PLUM SET IV TUBING WITH FILTER, 1.2 MICRO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; lake forest IL 60045
• MDR Report Key: 15855518
• MDR Text Key: 304293878
• Report Number: MW5113443
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12539-05
• Device Lot Number: 5841061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White