—#180487

Product

Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K173972
Affected lot / code info: All serial numbers

Why it was recalled

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

Root cause (FDA determination)

Software design

Action the firm took

Fresenius Medical Care issued via First Class Mail on 03-12-2020 Important Medical Device Correction Customer Notification explaining the issue, health risk and action to take: To clear the alarm, tum the machine power off for 30 to 45 seconds and turn back on. If the alarm has not been cleared, repeat the power off cycle again. If still not cleared, perform a manual blood return and remove the patient from the machine. Remove the machine from service and contact a qualified service technician. This alarm may reoccur even after a power cycle has been performed. true alarm will only occur when an externally powered USB device is connected. Refer to the Operators Manual Troubleshooting section for instructions. A Reply Form included for confirmation the consignee read and understands the notice sent to them and ask for number of machines corrected. A software solution is being created that addresses this situation. Once the software upgrade is available, an additional notification will be sent with instructions on how to order the upgrade at no charge. If you experience this issue or have additional questions, please contact Fresenius Medical Care Technical Services at 800-227-2572

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Foreign: Canada, Curaca, Guam

Timeline

Recall initiated: 2020-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180487. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.