MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-31 for FRESENIUS AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR / ALARM 2008T manufactured by Fresenius Usa, Inc..
[131897768]
At 1843 dialysis treatment was completed, the dialyzer was clear upon rinse back and the blood returned; bp 169/74, hr 72. At 1848, the pt was noted by the attending to be unresponsive and foaming at the mouth; 911 was activated at 1849. Dx: severe symptomatic acute hypernatremia. On monday (b)(6) 2018, a second pt was placed on machine #42, dialysis machine conductivity level 14. 0 and phoenix meter test 14. 0. About 1 hr and 15 min unto the treatment, the pt became diaphoretic and dizzy. The pt was immediately taken off of the machine, treatment completed without incident on machine #46. Machine #42 was removed from the dialysis suite, tagged not to be used and the lines were sequestered. At this time it was suspected that there was an equipment issue. Contacted mfr fresenius on wednesday (b)(6) 2018 requesting diagnostics. As per the (b)(6) 2018 mfr's report, they corrected the interchange feed tubing to acid and bicarb pumps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8207764 |
| MDR Report Key | 8207764 |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-10 |
| Date Facility Aware | 2018-12-19 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2019-01-02 |
| 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 | 0 |
| Brand Name | FRESENIUS AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR / ALARM |
| Generic Name | FRESENIUS 2008T DIALYSIS MACHINE |
| Product Code | ODX |
| Date Received | 2018-12-31 |
| Model Number | 2008T |
| Device Availability | Y |
| Device Age | 19 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-31 |