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 2017-08-10 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[82786336]
The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. A records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event. The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint. The lot passed all release criteria. Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
Patient Sequence No: 1, Text Type: N, H10
[82786337]
A nurse at the user facility reported that a blood leak occurred approximately 1 hour after the patent? S hemodialysis (hd) treatment was initiated. The leak was noted as being an internal blood leak from the dialyzer. A fresenius 2008t hd machine was in use during the event and generated a blood leak alarm. No damage was observed to the dialyzer or its packaging. The dialysate line was checked with a blood leak test strip and returned a positive result. The blood within the extracorporeal circuit was not returned to the patient. The patient was re-setup on a different 2008t hd machine, and then the hd therapy was continued and successfully completed with no further issues. The patient's estimated blood loss (ebl) was noted as being approximately 300 milliliters (ml). No patient adverse effects were experienced and no medical intervention was required as a result of this event. A fresenius bloodline was in use during the hd therapy. The dialyzer was not available to be returned to the manufacturer for analysis as it was discarded by the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00260 |
| MDR Report Key | 6786370 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-10 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-09-06 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2017-08-10 |
| 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 | 2017-08-10 |
| Catalog Number | 0500318E |
| Lot Number | 17DU03001 |
| 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 | 2017-08-10 |