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 2017-12-04 for OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E manufactured by Ogden Manufacturing Plant.
[93717505]
Plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[93717506]
A user facility reported that a blood leak occurred immediately after initiation of the patient's hemodialysis (hd) treatment. The blood leak was noted as being an internal dialyzer leak. The machine alarmed and blood test strips were used to positively confirm the presence of blood. Blood was not visually observed in the dialyzer. No dialyzer damage was visible. Additionally, no damage to the dialyzer packaging was observed. The patient? S estimated blood loss (ebl) was noted as being approximately 100cc. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient completed treatment with a new set-up on a different machine. The complaint device is not available for evaluation by the manufacturer as it was discarded by the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00381 |
| MDR Report Key | 7079234 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-12-04 |
| 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 | 2017-12-04 |
| Model Number | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. |
| Catalog Number | 0500316E |
| Lot Number | 17EU06025 |
| 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 | 2017-12-04 |