Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines
Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with functional monitoring failure. No illnesses or injuries have been reported. This is a risk-of-harm scenario where failure of critical vital sign monitoring during hemodialysis could result in patient harm. Per the rubric, this qualifies as High (Score 3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care is recalling 3,718 units of its 2008 Series Hemodialysis Machines equipped with BPM3 blood pressure monitoring modules (model TM-2917B, firmware version S005). These machines were distributed nationwide in the United States and Canada.
The recalled machines will not record blood pressure measurements if the cuff tubing becomes kinked close to the cuff. Additionally, the device will not alarm to alert healthcare providers when this monitoring failure occurs. This means medical staff may be unaware that blood pressure monitoring has stopped during a dialysis treatment session.
Blood pressure monitoring is critical during hemodialysis to detect dangerous changes in vital signs. When monitoring fails without triggering an alarm, healthcare providers cannot know that vital signs are no longer being recorded, creating potential for undetected hypertension or hypotension during treatment.
Patients and healthcare facilities should contact Fresenius Medical Care for guidance on the affected equipment. The FDA is requesting that healthcare providers ensure proper positioning of cuff tubing on affected machines to prevent kinking, and to verify that blood pressure monitoring is functioning correctly during each use.
The recalled product
- 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
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 3,718
Distribution
Distributed nationwide across the United States.
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