MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for COMBI-SET TRUE FLOW SERIES 8 MM PUMP SEGMENT 03-2722-9 manufactured by Fresenius Medical Care North America, Renal Therapies.
[91219386]
Approximately 1. 5 hours into a scheduled 4 hour hemodialysis treatment, blood was noted on the floor on the right side of the patient's chair. The venous bloodline was detached from the venous lumen of the central venous catheter. The blood pump was stopped and lumen clamped. Patient was unresponsive. Oxygen and aed were applied and cpr initiated. Phone number 911 was called. Normal saline was infused via arterial line. Patient was transported to the hospital via ems, where she later expired. Rn reported that hemaclips were applied to both arterial and venous lines at initiation of treatment.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 7003071 |
| MDR Report Key | 7003071 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-17 |
| Date Facility Aware | 2017-10-17 |
| Report Date | 2017-10-26 |
| Date Reported to FDA | 2017-10-26 |
| Date Reported to Mfgr | 2017-10-26 |
| Date Added to Maude | 2017-11-06 |
| 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 | 0 |
| 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 | 0 |
| Brand Name | COMBI-SET TRUE FLOW SERIES |
| Generic Name | HEMODIALYSIS BLOOD TUBING SET |
| Product Code | ONW |
| Date Received | 2017-11-02 |
| Model Number | 8 MM PUMP SEGMENT |
| Catalog Number | 03-2722-9 |
| Lot Number | 17JR01224 |
| 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, RENAL THERAPIES |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Death | 2017-11-02 |