DIAL FLOWMETER F10-2G0A3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-16 for DIAL FLOWMETER F10-2G0A3 * manufactured by Amvex Corporation.

Event Text Entries

[20737511] Ecmo extracorporeal membrane oxygenator sweep flowmeter was adjusted from 6 l/m liters per minute to 7 l/m. The flowmeter does not have a 7 l/m setting. It has settings at 6 then 8 l/m at the in between area there was no oxygen flow. The patient became hypoxic. The md was notified and the oxygen device was changed. During rounds, team wanted sweep to be turned from 6 to 7. At this time bedside rn notified ecmo and proceeded to increase sweep to 7. A few minutes later sats saturations began to drop significantly (lowest of 12%) as well as svo2 saturated venous oxygen (as low as 30%). Ecmo charge immediately called to bedside as well as attending md, rt respiratory therapist and charge rn. Attending at bedside with bedside rns assessing patient and ecmo equipment. Oxygen from wall appeared to be working at times and at others not, so ecmo flow meter attached to oxygen tank and sweep increased on dial per md. At this time, sats began to increase as well as svo2 saturated venous oxygen. At this time ecmo at bedside and explained that the ecmo sweep dial turns off when dial adjusted to 7 and needs to be changed to a different flow meter to increase sweep to 7. Sicu staff unaware of this information. Pt vitals returned to his norm with no apparent complications noted at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2065057
• MDR Report Key: 2065057
• Date Received: 2011-04-16
• Date of Report: 2011-04-16
• Date of Event: 2011-01-21
• Report Date: 2011-04-16
• Date Reported to FDA: 2011-04-16
• Date Added to Maude: 2011-04-20
• 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
• 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: DIAL FLOWMETER
• Generic Name: FLOWMETER
• Product Code: CAX
• Date Received: 2011-04-16
• Model Number: F10-2G0A3
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMVEX CORPORATION
• Manufacturer Address: 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-04-16