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).
Recall
- Recall Number
- Z-0443-2021
- Event Number
- 86577
- Firm
- Maquet Cardiovascular Us Sales, Llc
- FEI Number
- 3008355164
- Product Code
- DRY
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- September 30, 2020
- Terminated
- May 25, 2023
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
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).
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.
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.
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.
51 units