MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-03 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.
[107511385]
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
[107511386]
A user facility reported that a dialyzer blood leak that occurred at the beginning of the patient? S hemodialysis (hd) treatment. The blood leak was noted as being an external blood leak. The leak was noted in the upper head of the dialyzer. The patient? S estimated blood loss (ebl) was approximately 10 ml. There was no defect or damage seen on the dialyzer. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on the same machine and treatment completed successfully with new supplies. The complaint device was discarded and is not available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[123750319]
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[123750320]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2018-00131 |
| MDR Report Key | 7483759 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-03 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2018-05-03 |
| 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 |
| 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 F18NRE DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2018-05-03 |
| Catalog Number | 0500308E |
| Lot Number | 15LU02006 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-05-03 |