MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-29 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[93884933]
A follow up will be submitted following evaluation.
Patient Sequence No: 1, Text Type: N, H10
[93884934]
A user facility reported of a blood leak at the beginning of the patient's treatment. Blood left the dialyzer and leaked into the arterial hansen line. During follow up the clinic manager reported reported that the patient did not have a serious adverse event, he was moved to another machine. He lost 1 cycle or blood approximately 100 ml. The machine alarmed and blood was visible in the dialysate, no test strips were used. The dialyzer was discarded
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00378 |
| MDR Report Key | 7068813 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-29 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2017-08-27 |
| Date Added to Maude | 2017-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | 475 WEST 13TH STREET |
| Manufacturer City | OGDEN UT 84404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-11-29 |
| Model Number | . |
| Catalog Number | 0500318E |
| Lot Number | 17KU02017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Manufacturer Address | 475 WEST 13TH STREET OGDEN UT 84404 US 84404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |