MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK; STOPCOCK, I.V. SET

Model Number B90051

Device Problems Obstruction of Flow (2423); No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device will be requested to be returned, however, it has not yet been received.

Event Description

The event occurred on an unspecified date and involved a 9" smallbore ext set w/0.2 micron filter, clave®, clamp, check valve w/luer lock.It was reported that a 0.2 micron iv air filter clogged when an infusion was going overnight, leading to the patient decompensating and requiring interventions to keep their blood pressure pressures stable.

Manufacturer Narrative

Three used smallbore extension sets were returned for investigation and each of the three sets returned had evidence of fluid residuals within the inline 0.2 micron filters.Subsequent priming efforts confirmed the filters to be occluded.As the pressure was increased the filters cleared and the filter vents leaked.The probable cause of the observed filter vent leaks is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction.The inline filters were confirmed to be clogged during use.It is noted that a filter that clogs during infusion should be replaced.

• Brand Name: 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/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: 15782550
• MDR Text Key: 303561150
• Report Number: 9617594-2022-00300
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B90051
• Device Catalogue Number: B90051
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening