BARD HC70TS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-29 for BARD HC70TS * manufactured by Bard Vascular Systems Division.

Event Text Entries

[304087] Perfusionist assembled bypass machine and discovered hemoconcentrator was defective and leaking fluid at end.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029998
• MDR Report Key: 493762
• Date Received: 2003-10-29
• Date of Report: 2003-10-29
• Date of Event: 2003-10-09
• Date Added to Maude: 2003-11-07
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD
• Generic Name: HEMOCONCENTRATOR
• Product Code: KRI
• Date Received: 2003-10-29
• Model Number: HC70TS
• Catalog Number: *
• Lot Number: 110984A
• ID Number: *
• Device Expiration Date: 2003-12-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 482470
• Manufacturer: BARD VASCULAR SYSTEMS DIVISION
• Manufacturer Address: 25 COMPUTER DR HAVERHILL MA 01832 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-29