2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA device recall Z-1867-2024 · posted 2024-05-17 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Action taken
- On April 17, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer actions: As per the 2008T Operators Manual P/N 490122 Rev AA: Blood Pump Rotors should be inspected for proper operation, as stated in Chapter 2: Daily preparation for treatment. If you experience a dislodged guide post sleeve, bent or loose tubing guide posts, or roller cannot move freely on your current F40015481 Rev A blood pump rotor, please contact FMCRTG Technical Support Services at 800-405-1321 for a replacement Blood Pump Rotor (Part Number, F40015481, Rev C) . Have Rotor Lot Number available when requesting a replacement. Please provide this letter to your Biomedical Technician or trained personnel. Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. Provide this Customer Notice to all those who need to be aware within your organization. Complete and return the attached reply form. Biomedical Technician/ actions: A Field Service Bulletin will be posted to fmcna.com website regarding Preventative Maintenance activities for Blood Pump Rotor Tubing Guide Inspection of the need to inspect the blood pump tubing guides during the 6-month Preventive Maintenance on all 2008 Series Hemodialysis Machines. URL: https://fmcna.com/support/product-support-documents/field-service-bulletins/ For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 931 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-04-17
- Date posted
- 2024-05-17
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2008T BlueStar Hemodialysis Machine (K231125) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 |
| 2008T BlueStar Hemodailysis Machine (K222952) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 |
| 2008T BlueStar Hemodialysis Machine (K173972) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 |