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 2017-10-23 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[90744298]
A supplemental report will be submitted upon completion of the plant? S investigation.
Patient Sequence No: 1, Text Type: N, H10
[90744299]
A user facility nurse reported that a blood leak occurred approximately 1 hour after initiation of the patient's hemodialysis (hd) treatment. The leak was noted as being an external blood leak within the dialyzer. The patient was re-setup on the same machine, and then the hd therapy was completed. It was reported that the dialyzer had a crack on the venous side of the dialyzer leaking some from the crack. There was no observed damage to the dialyzer during the setup, prior to the treatment. The 2008k hd machine did not alarm as the leak was very small and did not lead to any internal blood leak. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient's estimated blood loss (ebl) was noted as being approximately 250-300 milliliters (ml). The dialyzer was not available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00334 |
| MDR Report Key | 6970702 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-23 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2017-10-23 |
| 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 | 2017-10-23 |
| Model Number | OPTIFLUX 180NRE DIALYZER |
| Catalog Number | 0500318E |
| Lot Number | 17KU02006 |
| Operator | NURSE |
| 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 | 2017-10-23 |