—#197048

Product

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

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: Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099

Why it was recalled

(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

Root cause (FDA determination)

Process design

Action the firm took

Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take: First, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter. Second, hardware issue that affects only CDX machines. To reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following: " Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader. o NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state drawing minimal/low current which can trip the sensing circuit. An example would be a USB corded optical mouse. Complete/Return the response form enclosed.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-07-27
Posted by FDA: 2022-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197048. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.