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 2017-10-07 for OPTIFLUX 180NRE DIALYZER 0500318E manufactured by Ogden Manufacturing Plant.
[89941292]
The device has not been returned to the manufacturer. A supplemental report will be filed upon completion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[89941293]
A peritoneal dialysis clinic manager reported that a saline bag ran dry, causing air to enter the dialyzer. This caused the lines to clot and subsequently caused blood loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00323 |
| MDR Report Key | 6926396 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-07 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-10-07 |
| 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 180NRE DIALYZER |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-10-07 |
| Catalog Number | 0500318E |
| Lot Number | 0100840861100156 |
| Operator | NURSE |
| 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 | 2017-10-07 |