MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Model Number B4018

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

It was reported that the stopcock infusing norepinephrine and propofol broke, leaking medication and blood from the patient.Patient was high vasopressor dependent running levophed at 40mcg/min and vasopressin at 0.06u/min.Patient's mean arterial pressure (map) dropped to 38.The reporter immediately identified the leak from the pool of fluid around the stopcock.400 mcg of phenylephrine was given with a verbal order from a clinical associate.A new stopcock was placed.The patient¿s blood pressure was slowly restored.There was patient involvement and no patient harm.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.

Manufacturer Narrative

Additional information: d9 - date returned to mfg 2/10/2023.The complaint of leakage can be confirmed on two (2) of the three (3) returned used.List #b4018, 4-way high flow stopcock w/rotating luer; lot #unknown.As received there was crazing and cracks observed on the female luers of two (2) of the three (3) returned stopcocks.The crack was observed to be axially down the length of the female luer.Each sample was leak tested per product specification.There was a leak observed on the two (2) stopcocks with cracks and crazing observed.The probable cause of the damage observed is typical of environmental stress during use.It is unknown if the devices received were involved in the reported event.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16292036
• MDR Text Key: 308914945
• Report Number: 9617594-2023-00058
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B4018
• Device Catalogue Number: B4018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• 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: NOREPINEPHRINE, UNK MFR; PROPOFOL, UNK MFR