Class 2 Device Recall Blood Pressure Module TM2917B

• Date Initiated by Firm: August 08, 2024
• Date Posted: September 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3124-2024
• Recall Event ID: 95169
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
• Code Information: UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 4T0S275804 4T0S276804 4T0S276814 4T0S276818 4T0S276829 4T0S276833 4T0S276838 4T0S276858 4T0S276867 4T0S276870 4T0S276807 4T0S276886 4T0S276894 4T0S276895 4T0S276897 4T0S276909 4T0S276911 4T0S276912 4T0S276916 4T0S276921 4T0S276926 4T0S276928 4T0S276934 4T0S276952 4T0S276960 4T0S276961 4T0S276963 4T0S276964 4T0S276965 4T0S276969 4T0S276973 4T0S276976 4T0S276979 4T0S276991 4T0S276998 4T0S276999 4T0S277004 4T0S277005 4T0S278031 4T0S278068 4T0S278087 4T0S278088 4T0S278105 4T0S278107 4T0S278109 4T0S278122 4T0S278124 4T0S278144 4T0S278149 4T0S278154 4T0S278157 4T0S278159 4T0S278183 4T0S278190 4T0S278193 4T0S278196 4T0S278198 4T0S278199 4T0S278206 4T0S278207 4T0S278217 4T0S278218 4T0S277002 4T0S277003 4T0S277025 4T0S277048 4T0S277054 4T0S277077 4T0S277090 4T0S277094 4T0S277095 4T0S277099 4T0S277115 4T0S277345 4T0S277355 4T0S277367 4T0S277371 4T0S277374 4T0S277380 4T0S277381 4T0S277392 4T0S277398 4T0S277419 4T0S277420 4T0S277424 4T0S277431 4T0S277434 4T0S277452 4T0S277459 4T0S277475 4T0S277762 4T0S277765 4T0S277775 4T0S277785 4T0S277787 4T0S277791 4T0S277793 4T0S277795 4T0S277800 4T0S277801 4T0S277802 4T0S277806 4T0S277807 4T0S277808 4T0S277812 4T0S277817 4T0S277818 4T0S277821 4T0S277822 4T0S277831 4T0S277860 4T0S277869 4T0S277582 4T0S277587 4T0S277606 4T0S277616 4T0S277635 4T0S277649 4T0S277655 4T0S277656 4T0S277682 4T0S277707 4T0S277711 4T0S277716 4T0S277723 4T0S277741 4T0S277746 4T0S277753 4T0S277755 4T0S277756 4T0S277757 4T0S277758 4T0S277360 4T0S277401 4T0S277545 4T0S277547 4T0S277565 4T0S277576 4T0S277609 4T0S277629 4T0S277633 4T0S277637 4T0S277643 4T0S277650 4T0S277653 4T0S277669 4T0S277671 4T0S277693 4T0S277706 4T0S277713 4T0S277714 4T0S277721 4T0S277724 4T0S277732 4T0S277736 4T0S277744 4T0S277749 4T0S277752 4T0S277754 4T0S276854 4T0S276884 4T0S276920 4T0S276924 4T0S276927 4T0S276935 4T0S276937 4T0S276938 4T0S276942 4T0S276953 4T0S276958 4T0S276959 4T0S276971 4T0S276974 4T0S276975 4T0S276977 4T0S276982 4T0S276984 4T0S276987 4T0S276989 4T0S276993 4T0S276994 4T0S276995 4T0S276996 4T0S276997 4T0S277001 4T0S277006 4T0S277016 4T0S277036 4T0S277102 4T0S277343 4T0S277393 4T0S277397 4T0S277399 4T0S277422 4T0S277429 4T0S277435 4T0S277445 4T0S277446 4T0S277451 4T0S277458 4T0S277461 4T0S277465 4T0S277481 4T0S277483 4T0S277485 4T0S277489 4T0S276375 4T0S276492 4T0S276534 4T0S276543 4T0S276553 4T0S276601 4T0S276602 4T0S276604 4T0S276605 4T0S276612 4T0S276618 4T0S276627 4T0S276647 4T0S276650 4T0S276652 4T0S276660 4T0S276664 4T0S278512 4T0S278514 4T0S278525 4T0S278529 4T0S278530 4T0S278534 4T0S278539 4T0S278545 4T0S278556 4T0S278560 4T0S278566 4T0S278577 4T0S278578 4T0S278579 4T0S278582 4T0S278585 4T0S278595 4T0S278601 4T0S278612 4T0S278619 4T0S278636 4T0S278639 4T0S278662 4T0S278666 4T0S278691 4T0S278693 4T0S278696 4T0S278703 4T0S278718 4T0S278720 4T0S278721 4T0S278722 4T0S275458 4T0S275469 4T0S275487 4T0S275491 4T0S275990 4T0S275994 4T0S276006 4T0S276009 4T0S276010 4T0S276017 4T0S276018 4T0S276020 4T0S276024 4T0S276028 4T0S276030 4T0S276031 4T0S276032 4T0S276033 4T0S276036 4T0S276037 4T0S276044 4T0S276047 4T0S276055 4T0S276057 4T0S278997 4T0S279015 4T0S279047 4T0S279062 4T0S279073 4T0S279088 4T0S279089 4T0S279093 4T0S279114 4T0S279123 4T0S279126 4T0S279150 4T0S279158 4T0S279159 4T0S279161 4T0S279177 4T0S279184 4T0S279188 4T0S279208 4T0S279211 4T0S279221 4T0S279230 4T0S277161 4T0S277167 4T0S277192 4T0S277200 4T0S277201 4T0S277212 4T0S277267 4T0S277335 4T0S277342 4T0S278597 4T0S276815 4T0S276823 4T0S276826 4T0S276832 4T0S276842 4T0S276843 4T0S276845 4T0S276849 4T0S276853 4T0S276861 4T0S276863 4T0S276872 4T0S276873 4T0S276874 4T0S276876 4T0S276877 4T0S276881 4T0S276883 4T0S276901 4T0S276908 4T0S277771 4T0S277833 4T0S277848 4T0S277855 4T0S277884 4T0S277886 4T0S277893 4T0S277894 4T0S277897 4T0S277899 4T0S277912 4T0S277915 4T0S277916 4T0S277929 4T0S277932 4T0S277938 4T0S277939 4T0S277940 4T0S277941 4T0S277943 4T0S277954 4T0S277955 4T0S277961 4T0S277962 4T0S277972 4T0S277975 4T0S277985 4T0S277997 4T0S278000 4T0S275460 4T0S275467 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• FEI Number: 3001451489
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St Bld 920; Waltham MA 02451-1521
• For Additional Information Contact: Fresenius Technical Service Team; 800-227-2572
• Manufacturer Reason for Recall: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
• FDA Determined Cause: Under Investigation by firm
• Action: An IMPORTANT MEDICAL DEVICE CORRECTION notification letter dated 8/8/24 was sent to customers. Facilities and Programs with the 2008T Hemodialysis Machine with Blood Pressure Module BPM3 should: "Visually inspect the blood pressure tubing for kinking during each monitoring and safety check. Correct any kinks if observed. "Verify visually that each scheduled blood pressure measurement was completed successfully each time period as per clinic procedures and state regulations. For further information please reference the 2008T Hemodialysis System Operator's Manual (P/N 490122 Rev. AA) https://fmcna.com/support/product-support-documents/operators-manuals-hemodialysis-hd/ Fresenius Medical Care is working diligently on a correction and will communicate when updated firmware is available. Please provide this Customer Notice to all those who need to be aware within your organization. Please complete and return the attached reply form. On 12/19/2024, Fresenius Medical sent a follow up notification letter indicating there is a new BPM3 Blood Pressure Module (firmware version S007) available that fixes this issue. Instructions included how to determine if you have affected BPM3 firmware and if it is affected, how to return the unit and order the replacement part. Customers were also instructed to notify personnel and customers, and to complete and return the response form.
• Quantity in Commerce: 3,718 systems
• Distribution: US Nationwide. Canada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.