MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-H1836

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The event involved a 13 cm (5") appx 0.33 ml, smallbore bifuse ext set w/2 microclave¿, rotating luer lock where a leaking port was reported.The status of the medical device at the time of event was when connected to central venous catheter (cvc) with an inotrope infusion running through.The syringe and line had recently been changed, but the device remained unchanged.The product was in clinical use at the time of event and extremely sensitive while switching vasopressin syringes.In the evening at 17:30 switched the vasopressin again with increasing noradrenaline first which helped.Twenty-five minutes after this the customer double pumped noradrenaline slowly.Twenty minutes into double pumping blood pressure (bp) dropped again, when doing so the blood pressure started to drop to 49.The reporter stated they called for help prior to this, and pef came to help.The customer had already restarted the old noradrenaline and stabilized bp and then they drew up x2 new noradrenaline quad strength and redouble pumped again slowly.Lines regularly checked but no clamps kinks or issues.Double pumping continued to take a while, but bp stabilized around 60-65.At hand over, while finishing double pumping, bp dropped dramatically called for help and crash bell pulled vasopressin line now leaking.New double pumping commenced on new line and blood started to back track on old microclave out of it leak found at the base of one of the blue bungs and reported to nic who has taken the microclave.Adrenaline and fluid bolus given bp increased.It was noted that the sheet was wet post changing of line and on examination after the patient had been stabilized, one side of the double bio connector appeared to be leaking when flushed from around the base of the blue bung and only one defective device was noted with the issue.There was a medical intervention provided and patient involvement.

Manufacturer Narrative

One of the microclave connectors was confirmed to have the seal stuck down when returned.Subsequent leak testing confirmed leakage from tearing on the top surface of the seal.The proximal 011-h1836 smallbore bifuse ext set met product performace expectations without leakage.The probable cause of the microclave stick down and leakage on the distal 011-h1836 smallbore bifuse assembly is typical of access with an incompatible mating device during use.The dfu states: needlefree connectors are compatible with iso male luers having an internal diameter between 0.062 inches (1.58 mm) and 0.110 inches (2.8 mm).The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 1/26/2024.Updated information in g4corrected information in d2.

• Brand Name: 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 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: 18527144
• MDR Text Key: 333045137
• Report Number: 9617594-2024-00037
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619013141
• UDI-Public: (01)00840619013141(17)280501(10)13649111
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1836
• Device Lot Number: 13649111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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: CENTRAL VENOUS CATHETER, UNK MFR; INOTROPE INFUSION, UNK MFR; NORADRENALINE, UNK MFR; UNSPECIFIED FLUID BOLUS, UNK MFR; VASOPRESSIN SYRINGE, UNK MFR
• Patient Outcome(s): Life Threatening; Required Intervention