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ROTAFLOW recallZ-0678-2020 · Maquet Cardiovascular Us Sales, Llc · initiated Dec 3, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-0678-2020
Status
Terminated
Initiated by the company
Dec 3, 2019
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Quantity
11 distributed in the US
Product code
KFM
FDA submissions
K991864
Distribution
The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.

Product description

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Code information (models, lots, serial numbers)

UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K991864 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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