D-STAT 4000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-28 for D-STAT 4000 * manufactured by Vascular Solutions.

Event Text Entries

[15681477] Pt had a tunneled hd catheter removed and tract was bleeding. Oozing from catheter exit site and tunnel despite manual hemostasis. Physician was in the process of administering the flowable form of d-stat (thrombin/collagen mixture) into the tract while maintaining manual pressure in the left ij venotomy site. The pt complained of not feeling well and became unresponsive. A code was called. It is suspected that the pt had a pulmonary embolism (pe). She suffered anoxic brain injury. Life support was withdrawn and the pt died eight days after event day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	766552
MDR Report Key	766552
Date Received	2006-09-28
Date of Report	2006-09-27
Date of Event	2006-09-07
Date Facility Aware	2006-09-07
Report Date	2006-09-27
Date Reported to Mfgr	2006-09-15
Date Added to Maude	2006-10-04
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	D-STAT
Generic Name	FLOWABLE HEMOSTAT
Product Code	MHW
Date Received	2006-09-28
Model Number	4000
Catalog Number	*
Lot Number	301228
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	754438
Manufacturer	VASCULAR SOLUTIONS
Manufacturer Address	6464 SYCAMORE CT MINNEAPOLIS MN 55367 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2006-09-28