Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Recall
- Recall Number
- Z-0678-2020
- Event Number
- 84377
- Firm
- Maquet Cardiovascular Us Sales, Llc
- FEI Number
- 3008355164
- Product Code
- KFM
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 3, 2019
- Terminated
- September 18, 2020
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
An Urgent Medical Device Recall notification letter dated 12/3/19 was sent to customers. If your affected RFD unit is in clinical use, switch to RPM mode. Using hospital patient management protocols and physician judgement, perform the following steps: 1. Check your inventory for an unaffected RFD unit . If an unaffected RFD unit is available, it should be at the clinicians discretion to transfer the patient from the affected unit to the unaffected unit. 2. If an unaffected RFD unit is unavailable or if temporary interruption of extracorporeal blood flow is not possible check the following options: a. Please check your inventory for an independent external flow measurement system to measure the actual flow. Only use a reliable external flow measurement that is gauged and zeroed. Use that measurement system in conjunction with the RPM mode. If necessary adjust the RPM according to the flow reading as obtained with the independent external flow measurement system. A continuous control of the patient vital signs monitoring is indicated. If the the Bubble Sensor intervention is already active, leave the setting in place. b. In case no external flow measurement system is available stay on RPM mode and continuously control vital signs monitoring. It is indicated to closely monitor the blood gases of the respective patient. The assessment of the vital sign monitoring and the blood gas analysis in conjunction with the indicated pump speed (RPM) is required. If the the Bubble Sensor intervention is already active, leave the setting in place. 3. When treatment of patient is completed, remove your affected RFD unit from use and follow the Actions to be Taken for return and repair below. If your affected RFD unit is not in clinical use, remove your affected RFD unit and follow the Actions to be Taken for return and repair below. Actions to be taken 1. Our records indicate that you have received a Rotaflow Drive Unit with a serial number that is affected by this
The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
11 distributed in the US