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 07/08/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation but it has not been received.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 reported this event as an adverse event with an outcome of patient hospitalization ¿ (initial or prolonged) and there was unspecified required intervention to prevent permanent impairment/damage (devices).The customer also feels that it was ¿user error" and as if it was not set related.There was patient involvement and adverse event.

Manufacturer Narrative

The complaint of device problem could not be confirmed.No product samples, pictures, or videos were received for investigation.The customer was connected and no further samples, sister samples or information could be provided.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Additional information: d9 - device available for evaluation.D9 - date returned to mfg null.

• 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: 15209710
• MDR Text Key: 297697896
• Report Number: 9617594-2022-00234
• 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,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/17/2022
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG