MAUDE Adverse Event Report: BD BD POSI FLUSH PRE FILLED SALINE SYRINGE

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Cardiac Arrest (1762); Death (1802)

Event Date 12/14/2017

Event Type  Death  

Event Description

Pt new to dialysis less than two weeks.Just finished treatment, prefilled saline bd posi flush given through lines to flush neck cath, pt went into syncope and then cardiac arrest, 911 called, regained pulse before transport but died same day.Dose or amount: 20 ml millilitre(s).Route: intravenous.Diagnosis or reason for use: dialysis flush lines.

• Brand Name: BD POSI FLUSH PRE FILLED SALINE SYRINGE
• Type of Device: POSI FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 7133807
• MDR Text Key: 95511416
• Report Number: MW5074116
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Weight: 99