Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S

FDA device recall Z-3124-2024 · posted 2024-09-11 · Open, Classified

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KDI

Quantity affected

3,718 systems

Distribution

US Nationwide. Canada.

Date initiated

2024-08-08

Date posted

2024-09-11

Location

Waltham, MA