MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-17 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[93072554]
The plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[93072555]
A user facility healthcare professional reported that a blood leak occurred during a patient's hemodialysis (hd) treatment. The blood leak was discovered early in the patient? S treatment, though it was unknown exactly how far into treatment the event occurred. The machine alarmed as appropriate and blood was visually observed near the header cap in the dialyzer. Blood test strips were used and positively confirmed the presence of blood. There was no visible damage or defects noted to the used dialyzer. The patient? S estimated blood loss (ebl) was noted as being approximately 300ml to 400ml. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient completed treatment with a new set-up of supplies on a different machine. The complaint device was discarded and is no longer available for evaluation. Additional information was requested but was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00362 |
| MDR Report Key | 7041024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-11-17 |
| Device Manufacturer Date | 2017-09-10 |
| Date Added to Maude | 2017-11-17 |
| 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 | 2017-11-17 |
| Catalog Number | 0500318E |
| Lot Number | 17LU01007 |
| 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 | 2017-11-17 |