MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-23 for F6 DIALYZER FINISHED ASSY (CASE) manufactured by Ogden Manufacturing.
[1705034]
A medwatch report has been received regarding an event which occurred (b)(6) 2010. This facility has been contacted for further detail regarding this incident. Reportedly, the pt had been receiving dialysis when an internal blood leak was detected. The leak was reported as "gross" in that visible blood could be seen entering the dialysate. The leak was approximately 157cc's of blood loss and no blood was returned to the pt. The pt required no medical intervention, however, a blood transfusion had been considered. The pt is reported as being fine and a companion sample is available for an eval. Samples are available for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2010-00030 |
| MDR Report Key | 1828681 |
| Report Source | 05,06 |
| Date Received | 2010-08-23 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-07-12 |
| Date Facility Aware | 2010-07-12 |
| Report Date | 2010-08-23 |
| Date Reported to FDA | 2010-07-29 |
| Date Reported to Mfgr | 2010-07-28 |
| Date Mfgr Received | 2010-07-28 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-01-24 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARGARET CHARETTE, RN |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F6 DIALYZER FINISHED ASSY (CASE) |
| Generic Name | NONE |
| Product Code | MSE |
| Date Received | 2010-08-23 |
| Model Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-23 |