* LH130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-01-27 for * LH130 manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[16834688] During open heart surgery, air entered the patient's aorta, requiring immediate clamping of the aorta and steep trendelenburg (head down) positioning of the patient to prevent air embolism to the patient's head. Surgeon suspected that the terumo over pressure safety valve failed, allowing air into the aorta through the aortic root cannula and cardioplegia cannula system. The patient exhibited symptoms of right cerebrovascular accident (stroke) postoperatively with left sided weakness, which resolved within 3 days.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1298803
• MDR Report Key: 1298803
• Report Source: 99
• Date Received: 2009-01-27
• Date of Report: 2009-01-18
• Date of Event: 2008-12-12
• Date Facility Aware: 2009-01-18
• Report Date: 2009-01-23
• Date Reported to FDA: 2009-01-26
• Date Reported to Mfgr: 2009-01-26
• Date Added to Maude: 2009-02-04
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: OVERPRESSURE SAFETY VALVE
• Product Code: MNJ
• Date Received: 2009-01-27
• Returned To Mfg: 2009-01-21
• Model Number: LH130
• Catalog Number: *
• Lot Number: KF05
• ID Number: *
• Device Expiration Date: 2011-04-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TERUMO CARDIOVASCULAR SYSTEMS CORP.
• Manufacturer Address: * ELKTON MD * US *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2009-01-27