Recall Z-3124-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
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
| Date | Sep 11, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| Reason | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff. |
| Root cause | Under Investigation by firm |
| Action | An IMPORTANT MEDICAL DEVICE CORRECTION notification letter dated 8/8/24 was sent to customers. Facilities and Programs with the 2008T Hemodialysis Machine with Blood Pressure Module BPM3 should: "Visually inspect the blood pressure tubing for kinking during each monitoring and safety check. Correct any kinks if observed. "Verify visually that each scheduled blood pressure measurement was completed successfully each time period as per clinic procedures and state regulations. For further information please reference the 2008T Hemodialysis System Operator's Manual (P/N 490122 Rev. AA) https:/ |
| Quantity | 3,718 systems |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.