MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14001-31

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported, on an unknown date in november, a primary plum set transparent disposable generated a leak during usage in a patient.When initiating the infusion, it was noted that the set was dripping/leaking.It was not reported that the set was contaminated, presented any biological risk, or contained any chemotherapeutic agent and that medicines were used with the set.The set was not reprocessed or re-sterilized.There was a delay in therapy, however, no one was harmed, and was not reported that an adverse event occurred as a result of this event.This is report seven of eight.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• 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: 18422694
• MDR Text Key: 331667662
• Report Number: 9615050-2023-00827
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100883
• UDI-Public: (01)10887709100883(17)251001(10)8075764
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14001-31
• Device Lot Number: 8075764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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: UNSPECIFIED FLUID, UNK MFR.