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 2017-09-06 for OPTIFLUX 200NRE DIALYZER FINISHED ASSY. 0500320E manufactured by Ogden Manufacturing Plant.
[85368790]
A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[85368851]
A clinic manager reported there was a large blood leak observed as soon as the blood hit the dialyzer and went directly in to the red hanson, turning the red hanson tubing red. Follow-up was made with the clinic charge nurse, who stated the patient was connected to the 2008k hd machine when the blood leak was observed. The 2008k hd machine generated a blood leak alarm approximately 15 minutes after the hd therapy was initiated. The patient? S dialysate flow rate (dfr) was 800 and the patient? S blood flow rate (bfr) was 550. The nurse stated the bloodlines used were fresenius. The leak was noted as being an internal blood leak within the dialyzer, and no external leak was noted. No damage to the dialyzer or packaging was observed. It was unknown how much blood was lost, but stated there was enough blood to be noted in the hansen connectors. The charge nurse stated a blood leak test strip was not used. Per rn no patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient dialyzes 3 times a week and has been on hd since 2016. The patient was able to complete treatment with new supplies on another machine. Per rn the sample was discarded and was not available to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00287 |
| MDR Report Key | 6845511 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-09 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2017-06-16 |
| Date Added to Maude | 2017-09-06 |
| 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 200NRE DIALYZER FINISHED ASSY. |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER FJI DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-09-06 |
| Catalog Number | 0500320E |
| Lot Number | 17HU04019 |
| 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 | 2017-09-06 |