MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-02 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.
[99194725]
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[99194726]
A user facility in (b)(6) reported that a dialyzer blood leak occurred approximately ten minutes after the initiation of a patient? S hemodialysis (hd) treatment. The machine alarmed for blood leak and blood was visually observed in the base of the dialyzer fibers. Blood test strips were not used to positively confirm the presence of blood as the leak was visually seen by staff. The patient? S dialysate flow rate (dfr) was 500ml/min and the blood flow rate (bfr) was 300ml/min. The patient? S estimated blood loss (ebl) was noted as being approximately 110ml as the patient? S blood was not returned. No patient adverse effects were experienced, and no medical intervention was required. The patient completed treatment with a new set-up of supplies on the same machine. The complaint device is not available to be returned to the manufacturer for evaluation as it has been discarded by the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2018-00049 |
| MDR Report Key | 7238274 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-02 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2015-09-27 |
| Date Added to Maude | 2018-02-02 |
| 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 F18NRE DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2018-02-02 |
| Model Number | OPTIFLUX F18NRE DIALYZER FINISHED ASSY |
| Catalog Number | 0500308E |
| Lot Number | 15LU02006 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-02-02 |