Recall Z-0443-2021 · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Maquet Cardiovascular Us Sales, Llc

Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

Date	Sep 30, 2020
Status	Terminated
Reason	The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
Root cause	Under Investigation by firm
Action	On September 30, 2020, the firm issued an Urgent Medical Device Recall letter to all affected consignees. Customers were informed that the printed circuit board assembly for the affected devices are not in compliance with the IEC standard. Actions to be taken by the user: -Please examine your inventory immediately to determine if you have a BMU 40 with any of the affected serial numbers. The serial number tag is on the rear of the device. -Your facility may continue to use the BMU 40 pending replacement of the PCBA Connector, by adhering to the following recommendations: Use the equipotent
Quantity	51 units
Distribution	Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia,
FDA record	Open on fda.gov

510(k) clearances named in this recall

K090147

BLOOD MONITORING UNIT, MODEL BMU 40
Maquet Cardiopulmonary, AG, Apr 22, 2009