| Date Initiated by Firm |
December 03, 2019 |
| Create Date |
December 12, 2019 |
| Recall Status1 |
Terminated 3 on September 18, 2020 |
| Recall Number |
Z-0678-2020 |
| Recall Event ID |
84377 |
| 510(K)Number |
K991864
|
| Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
|
| Product |
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. |
| Code Information |
UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680 |
Recalling Firm/
Manufacturer |
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
|
| For Additional Information Contact |
Maryanna Krivak
973-709-7483
|
Manufacturer Reason
for Recall |
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
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 |
| Quantity in Commerce |
11 distributed in the US |
| Distribution |
The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA. |
| 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 = KFM and Original Applicant = JOSTRA MEDIZINTECHNIK AG
|
