MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-03-06 for F80A DIALYZER FINISHED ASSY 0500154A manufactured by Ogden Manufacturing.
[4454592]
A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred. The leak was visually observed from the head of the dialyzer and the machine alarmed. Estimated blood loss was 20cc's. Pt had no adverse effects and required no medical intervention. Sample has not been returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5
[11819320]
The plant investigation has not yet been completed. A f/u report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2014-00094 |
| MDR Report Key | 3837857 |
| Report Source | 05,06,07 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-06-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER NABUKENYA |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 8006621237 |
| Manufacturer G1 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | 475 WEST 13TH ST. |
| 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 | F80A DIALYZER FINISHED ASSY |
| Product Code | MSE |
| Date Received | 2014-03-06 |
| Catalog Number | 0500154A |
| Lot Number | 13EU03006 |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4008 | 2014-03-06 |