MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for FRESENIUS MEDICAL CARE COMBISET TRUE FLOW SERIES UNK 03-2742-9 manufactured by Fresenius Medical Care North America Rtg.
[127455624]
Pt attended scheduled hemodialysis treatment. Pt was alert, calm and lethargic. Predialysis bp 162/78, pulse 69, temp 96. 8, resp 17. Hemodialysis was initiated via right internal tunneled jugular catheter. At approx 1513 dialysis initiated. Within mins unable to achieve prescribed blood flow rate. The venous bloodline was then reversed and connected to the pt's arterial (red) catheter port and the arterial bloodline was connected to the pt's venous (blue) catheter port. The hemaclip was secured to the venous bloodline and the pt's arterial catheter port. Hemodialysis treatment was resumed, bp 176/78, pulse 69, blood flow rate at 350. At approx 1530 the pt was noted to have difficulty breathing, was pale in color, the pt's right fingers and side of shirt noted with blood. The venous bloodline and the pt's arterial (red) port had become disconnected with the hemaclip remaining in place. The pt's catheter ports were clamped, approx 750ml of normal saline administered, 911 and cpr initiated. Pt transported to er. Expired in er at approx 1616.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8077637 |
| MDR Report Key | 8077637 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-27 |
| Date Facility Aware | 2018-10-27 |
| Report Date | 2018-11-07 |
| Date Reported to FDA | 2018-11-08 |
| Date Reported to Mfgr | 2018-11-08 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS MEDICAL CARE COMBISET TRUE FLOW SERIES |
| Generic Name | HEMODIALYSIS BLOOD LINES |
| Product Code | FJK |
| Date Received | 2018-11-14 |
| Model Number | UNK |
| Catalog Number | 03-2742-9 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA RTG |
| Manufacturer Address | WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1000 | 1. Death; 2. Life Threatening | 2018-11-14 |