| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00324-1 |
| Product Name/Description |
multiFiltratePRO devices
(Haemodialysis system)
Product Code: M205001
ARTG Number: 257513 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Customer reports regarding the inadvertent opening of the blood leak detector (BLD) doors prior to commencement of treatment have been received by the manufacturer. Further investigations have revealed that it is not possible to rule out the risk of the inadvertent door opening, including during treatment.
An open BLD door allows the filtrate tube to slip out. However, a device error message only appears if this happens prior to the filtrate tube being filled during preparation. If the tube moves out of the BLD during treatment and this is not noticed, the device may not detect a blood leak in the filter. The BLD door is more likely to open inadvertently if tubes are inserted incorrectly (e.g., incorrect segment of the filtrate tubing system). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fresenius Medical Care (FMC) is advising users to route the tube in accordance with the requirements in the Instructions for Use (IFU) and on the screen. Users are further advised to conduct regular checks to ensure that the catch mechanism of the BLD door is operating fully and correctly especially, in particular, if the tubing system has been moved. Customers will be contacted by FMC regarding a free refitting solution in May 2017.
This action has been closed out on 19/10/2018 |
| Contact Information |
02 9466 8048 - Fresenius Medical Care (FMC) |