Recall – Dialysis machine detects incorrect heater bag volume

Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report: 11/18/2020
Class II

PRODUCT

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Recall Number: Z-0439-2021

REASON

The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.

RECALLING FIRM/MANUFACTURER

Fresenius Medical Care Holdings, Inc. on 9/18/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

9,907 devices

DISTRIBUTION

U.S. Nationwide

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
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