MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 110" (279 CM) APPX 20.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, 2 GANG 4-WAY ST; STOPCOCK, I.V. SET

Model Number B99078

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Without the return of the device a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history report could not be reviewed because no lot number was provided.Uf/importer report # is (b)(4).

Event Description

The event involved a 110" (279 cm) appx 20.5 ml, 15 drop primary set w/2 microclave®, 2 gang 4-way stopcocks, rotating luer where it was reported that the patient developed air emboli during atrial fibrillation ablation in the hospital ¿ electrophysiology lab.It was also reported that they had two events in the cath lab last week with patients that caused permanent harm and both instances occurred with a pressure bag/normal saline on the tubing.The customer also feels that it was ¿user error" and as if it was not set related.There was patient involvement and adverse event.

• Brand Name: 110" (279 CM) APPX 20.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, 2 GANG 4-WAY ST
• 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: 15209703
• MDR Text Key: 297699133
• Report Number: 9617594-2022-00233
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B99078
• Device Catalogue Number: B99078
• Device Lot Number: UNKOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NORMAL SALINE, MFR UNK
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male