ANGIOJET STERILE PUMPSET 102184-001 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-23 for ANGIOJET STERILE PUMPSET 102184-001 * manufactured by Possis Medical, Inc.

Event Text Entries

[1187081] Drip chamber on possis leaking, resulting in loss of pressure, delay of mechanical thrombolysis -<15 min.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5012165
• MDR Report Key: 1431470
• Date Received: 2009-07-23
• Date of Report: 2009-07-23
• Date of Event: 2009-06-30
• Date Added to Maude: 2009-08-11
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ANGIOJET STERILE PUMPSET
• Generic Name: POSSIS ANGIOJET
• Product Code: DXE
• Date Received: 2009-07-23
• Model Number: 102184-001
• Catalog Number: *
• Lot Number: 91735
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: POSSIS MEDICAL, INC
• Manufacturer Address: 9055 EVERGREEN BLVD. W. MINNEAPOLIS MN 55433800 US 55433 8003

Device Sequence Number: 2

• Brand Name: NON-STERILE COLLECTION BAG
• Generic Name: NONE
• Product Code: LIO
• Date Received: 2009-07-23
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: POSSIS MEDICAL, INC.
• Manufacturer Address: 9055 EVERGREEN BLVD. W. MINNEAPOLIS MN 55433800 US 55433 8003

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-07-23