MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHECK VALVE WITH MALE/FEMALE LUER LOCK; STOPCOCK, I.V. SET

Model Number 011-CS25

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Awareness during Anaesthesia (1707); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/20/2022

Event Type  Injury  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event involved a check valve with male/female luer lock where it was reported on the neurosurgical intensive care unit, during a round, a patient was found reactive to the medical care, hypertensive and disconnected from the respirator.The patient should have been sedated.The medical care team observed that the check-valve was cracked and that there was a flow of liquid, as hypnovel, sufentanyl and propofol were flowing on this line.This resulted in unwanted suppression of sedation, rebound of intracranial hypertension with risk of cerebral damages, even death for this patient.The valve was then changed.There was patient involvement and adverse event.

Event Description

Additional information received from the customer stating the valve had to be changed and the patient was monitored.There was a risk of cerebral engagement.The drugs were replaced and the therapy continued and the patient was put to sleep.This incident extended the hospital stay.There was no report of blood loss, however there was a delay in therapy because the patient was not sedated.

Manufacturer Narrative

Additional information in b5.

Manufacturer Narrative

Device received on 2/2/2023 for evaluation.Received one used.List #011-cs25, check valve with male/female luer lock; lot #5600058 and one new.List #011-cs25, check valve with male/female luer lock; lot #5600058.As received an axial crack was observed at the female luer of the returned list #011-cs25, check valve with male/female luer lock; lot #5600058.The crack propagated through the gate.There was no damage on the new 011-cs25.Each sample was leak tested per product specification.There was a leak at the crack on the used sample.There was no leakage on the new sample.The new sample met product specifications.The reported complaint of leakage can be confirmed on the returned one used.List #011-cs25, check valve with male/female luer lock; lot #5600058 due to the crack observed on each sample.The damage observed is typical of an environmental stress cracking during use.The device history review (dhr) for lot 5600058 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: CHECK VALVE WITH MALE/FEMALE LUER LOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16078357
• MDR Text Key: 306435936
• Report Number: 9617594-2022-00344
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 011-CS25
• Device Catalogue Number: 011-CS25
• Device Lot Number: 5600058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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: HYPNOVEL, UNK MFR.; PROPOFOL, UNK MFR.; RESPIRATOR, UNK MFR.; SUFENTANYL, UNK MFR.
• Patient Outcome(s): Required Intervention; Life Threatening