MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PRIMARY PORT CLAVE Y-SITE SECURE LOCK PRIMARY PLUM SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Failure to Deliver (2338); Air/Gas in Device (4062)

Patient Problems Awareness during Anaesthesia (1707); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The reported complaint occurred on an unknown date and involved an unspecified primary port clave y-site secure lock primary plum set.The tubing malfunctioned and there was a significant amount of air in the upper portion of the tubing.The patient awoke as propofol was not running.The tubing was set up per instructions with an open valve.The defective tubing was removed and a new set up was placed on the patient.There was no harm reported.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.A photograph was provided by the customer and evaluation of the photo is pending.

Manufacturer Narrative

A series of photos were shared by customer that illustrated an inconsistent flow of fluid passing through from the drip chamber, a stick down condition on the clave, and an unknown pump set.No leaks, occlusions or physical damages were observed in the photos.The reported complaint of product incorporates / allows air can be confirmed based on the stick down condition photo shared by customer.Without the return of the used physical sample a comprehensive evaluation of this failure mode cannot be performed and an investigation cannot be determined.Updated information can be found in d9.

• Brand Name: UNSPECIFIED PRIMARY PORT CLAVE Y-SITE SECURE LOCK PRIMARY PLUM SET
• 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: 17719708
• MDR Text Key: 323073610
• Report Number: 9615050-2023-00413
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: PROPOFOL, MFR UNK.