MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142550489

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The incident involved a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch.It was stated in the report that the product has been found to be leaking through the small hole on the filter.It was noticed toward the end of the infusion.There was unprotected chemo exposure to the patient or healthcare provider.When asked how was the patient or healthcare provider, the customer answered that they were okay.The healthcare provider wore personal protective equipment (ppe) or gloves during the event.There was patient involvement and unknown human harm.This is the first of two reports.

Manufacturer Narrative

Received forty-two (42) new 142550489 primary plumsets for inspection.No damages or anomalies noted.Each set was leak tested per product specifications.There was leakage at the outlet or inlet filter vents on six (6) of the forty-two (42) returned sets.A red dye test was conducted on one (1) of the leaking sets to evaluate where the leak was coming from.A small centralized leak of red dyed water was found in the middle of the outlet filter vent.The cause of the observed leak was a pinhole in the filter vent material.The damage is typical of a electrostatic discharge to the filter vent.The source of the electrostatic discharge build up is unknown.Filter vent leaks are currently under further investigation at the manufacturing location in costa rica.

• Brand Name: PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17864720
• MDR Text Key: 325840220
• Report Number: 9615050-2023-00499
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)260401(10)13548035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142550489
• Device Lot Number: 13548035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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
• Treatment: KADCYLA, MFR UNK.