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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Monitoring Unit (BMU 40)

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  Class 2 Device Recall Blood Monitoring Unit (BMU 40) see related information
Date Initiated by Firm September 30, 2020
Create Date November 12, 2020
Recall Status1 Terminated 3 on May 25, 2023
Recall Number Z-0443-2021
Recall Event ID 86577
510(K)Number K090147  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product 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).
Code Information Serial numbers 90002022 90002134 90002163 90002187 90002276 90002297 90002023 90002135 90002164 90002188 90002277 90002298 90002024 90002136 90002168 90002191 90002279 90002302 90002029 90002137 90002170 90002194 90002280 90002306 90002047 90002140 90002172 90002195 90002281 90002312 90002112 90002143 90002181 90002196 90002287 90002313 90002123 90002144 90002183 90002210 90002289 90002124 90002160 90002184 90002212 90002293 90002133 90002161 90002185 90002273 90002296
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Rachana Patel
973-709-7412
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 equipotential bonding connector on the rear of the BMU 40 ¿ Properly ground any accessory equipment connect to the BMU 40 ¿ Do not connect external devices to the BMU 40 serial ports (Com 1 /Com 2) with an operational/ communication voltage exceeding ¿25 VDC. See Figure 2 below. ¿ Use standard PPE (e.g. nitrile gloves) while operating the BMU 40 ¿ Follow IFU recommendations including avoid simultaneous contact with the patient and device. ¿ Getinge has developed a correction that will be available in Q1 2021. ¿ Should you require a loaner unit while service is being performed on your affected unit, Getinge will provide you a loaner unit when available, prior to the return of your affected unit to Getinge. ¿ Please complete and sign the included MEDICAL DEVICE CORRECTION  RESPONSE FORM Getinge has developed a correction that will be available in Q1 2021. Once available, Getinge will contact the person you listed on the Response Form to arrange shipment of the affected BMU 40 unit to the Getinge Service Center in New Jersey. The BMU 40 will be returned to your facility upon completion of the correction. You may also call Getinge Tech Support at (888) 9GETUSA / (888) 9438872 Option 4,2,1 between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.
Quantity in Commerce 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, Malta, Netherlands, Norway, Pakistan, Peru, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRY and Original Applicant = MAQUET CARDIOPULMONARY AG
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