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
- Recall Number
- Z-3194-2018
- Event Number
- 80875
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- FEI Number
- 3001451489
- Product Code
- KDI
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 13, 2018
- Terminated
- September 17, 2019
- Address
- 920 Winter St, Waltham, MA, 02451-1521
Description
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.
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.
On 07/13/2018 phone calls were immediately conducted to the affected clinics. Contact was made to the Technical Service Directors explaining issue and to disable the Auto Start Function on their BlueStar SW v2.71 installed 2008T Hemodialysis Machines.
US Nationwide in the states of : CA, CT, MI, NC, and NY.
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