Recall – Power failure confuses software

Company: Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report: 9/26/2018
Class II:

PRODUCT
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138

Product Usage: Indicated for acute and chronic dialysis therapy

Recall Number: Z-3194-2018

REASON
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient. .

RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA on 7/13/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
80

DISTRIBUTION
US Nationwide in the states of : CA, CT, MI, NC, and NY.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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