Recall Z-0678-2020 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
| Date | Dec 3, 2019 |
| Status | Terminated |
| Reason | A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. |
| Root cause | 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 op |
| Quantity | 11 distributed in the US |
| Distribution | The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991864 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM Jostra Medizintechnik AG, Aug 31, 2000 |