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 2017-08-03 for OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E manufactured by Ogden Manufacturing Plant.
[81808026]
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
[81808027]
The acute inpatient program manager at the user facility reported that an internal blood leak occurred during the patent? S hemodialysis (hd) treatment. The 2008t hd machine generated a blood leak alarm. Blood was observed within the dialysate of the dialyzer filter. The blood within the extracorporeal circuit was not returned to the patient. 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. The patient was re-setup on a different hd machine, and then the hd therapy was continued and successfully completed with no further issues. No damage or defects were visible to the dialyzer or its packaging. A fresenius bloodline was not in use. 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 | 1713747-2017-00256 |
| MDR Report Key | 6763348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-03 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-07-05 |
| Device Manufacturer Date | 2017-02-22 |
| Date Added to Maude | 2017-08-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 160NRE DIALYZER FINISHED ASSY. |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-08-03 |
| Catalog Number | 0500316E |
| Lot Number | 17BU06023 |
| 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 | 2017-08-03 |