MAUDE Adverse Event Report: CAREFUSION ALARIS 4-WAY STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10012496

Device Problems Structural Problem (2506); Difficult to Open or Close (2921)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Embolism (1829)

Event Date 03/10/2015

Event Type  Injury  

Event Description

Received a copy of the customer's medsun report which states "patient having pci (percutaneous coronary intervention), stable for stent into the circumflex.During the procedure, inadvertently introduced air into the coronary artery.This occurred during second stent deployment to the lad (left anterior descending artery).The patient complained of chest pain.On the ekg, st elevation in leads 2, and 3, then bradycardia, then asystole and pea (pulseless electrical activity).Code blue called and cpr started.The patient was shocked x 4 for vfib, epi x2 given, atropine xi given, and bagged by resp therapist.Transferred to intensive care." there is no further patient or event information.

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Manufacturer Narrative

Correction to initial reporter address.

• Brand Name: ALARIS 4-WAY STOPCOCK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 4950008
• MDR Text Key: 6250768
• Report Number: 9616066-2015-00917
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

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: 10012496
• Device Catalogue Number: 10012496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 63 YR