MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number 011-AM6118

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a proximale - 28 cm (11") smallbore ext set w/6-port nanoclave® manifold, check valve, nanoclave® (red rings), rotating luer where it was reported that the equipment was in place at the level of the proximal line to the patient's central line.Noradrenaline was administered because the patient was hypotensive and after a few minutes the blood pressure was still not satisfactory despite an increase in the dose of noradrenaline.The customer noticed a product leak on the sheet.Leak at the level of the llm connection of the device.Clinical consequence: hypotension which aggravates the patient's clinical condition.This incident took place in surgical intensive care.The patient's condition showed no improvement of the hypotension for approximatively thirty minutes, the time it took to notice the leak.Afterwards, the hypotension was resolved although it persisted.There was a delay in therapy of thirty minutes, the time it took to notice the issue.There was no need for medical intervention.There was patient involvement but no report of human harm.

Manufacturer Narrative

D9 - date returned to mfg is 8/9/2023.The single used 011-am6118 ext set w/6-port nanoclave manifold was pressure leak tested and leakage was observed at the bonded connection between the male luer at the distal end of the 6-port nanoclave manifold and the female luer on the extension set.The female luer was observed to have an incomplete connection to the male luer of the manifold resulting in leakage.The probable cause of the leakage is an incomplete bond connection during manual assembly.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA
• 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: 15940820
• MDR Text Key: 308350961
• Report Number: 9617594-2022-00319
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AM6118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 09/11/2023
• 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: NORADRENALINE, MFR UNK.