MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-05 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.
[135196087]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[135196088]
A user facility reported that a dialyzer blood leak occurred 2 minutes after the initiation of the patient? S hemodialysis (hd) treatment. The blood leak was noted as being an internal blood leak. The leak was not visually observed. The patient? S estimated blood loss (ebl) was approximately 1ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a new machine and treatment completed successfully with new supplies. The complaint device was reported to not available for return to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2019-00040 |
| MDR Report Key | 8307702 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-02-05 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| 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 F18NRE DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2019-02-05 |
| Catalog Number | 0500308E |
| Lot Number | 18EU01018 |
| 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 | 2019-02-05 |