MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for FRESENIUS OPTIFLUX 160NR DIALYZER 160 NR 0500316E manufactured by Fresenius.
[87805746]
Treatment initiated at approx 11:07am. At approx 1145am, the dialysis machine alarmed blood leak detector. A test was performed on the dialysate obtained from the arterial hanson connector, which was positive for blood using a blood leak test strip indicator. Hemodialysis treatment was interrupted, the optiflux 160nr was replaced and treatment continued. At approx 1230pm, the machine alarmed blood leak detector. A test was performed on the dialysate obtained from the arterial hanson connector, which was positive for blood using a blood leak test strip indicator and blood was visible in the dialysate from the arterial hanson connector. At approx 1233pm, the pt was noted to be unresponsive. Bp was 105/65 at 1230pm and cpr was initiated at 1233pm. Aed applied, rhythm analyzed, no shock advised. Ems transported pt to the hospital, pt expired on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6900484 |
| MDR Report Key | 6900484 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-11 |
| Date Facility Aware | 2017-09-11 |
| Report Date | 2017-09-14 |
| Date Reported to FDA | 2017-09-14 |
| Date Reported to Mfgr | 2017-09-14 |
| Date Added to Maude | 2017-09-28 |
| 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 OPTIFLUX 160NR DIALYZER |
| Generic Name | FRESENIUS OPTIFLUX 160NR DIALYZER |
| Product Code | FJI |
| Date Received | 2017-09-14 |
| Model Number | 160 NR |
| Catalog Number | 0500316E |
| Lot Number | 17CU06028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2017-09-14 |