MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-06 for F6 DIALYZER FINISHED ASSY (CASE) 0500145A manufactured by Ogden Manufacturing.
[18284496]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18374643]
A report has been received regarding an event which occurred from a hemodialysis user facility. Reportedly, the pt had been receiving dialysis treatment when an internal blood leak was detected. The leak was reported as? Gross? In that visible blood could be seen entering the dialysate. There was an approximate 157 ml of blood loss since no blood was returned to the pt. The pt required no medical intervention; however, a blood transfusion was considered. The facility was contacted regarding this event. It was learned that the pt is fine with no ill effect. Also, no further info will be released. A companion sample is available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2010-00027 |
| MDR Report Key | 1791393 |
| Report Source | 05,06 |
| Date Received | 2010-08-06 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-07-08 |
| Date Facility Aware | 2010-07-08 |
| Report Date | 2010-08-06 |
| Date Reported to Mfgr | 2010-07-08 |
| Date Mfgr Received | 2010-07-08 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-03-30 |
| 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 | 3 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F6 DIALYZER FINISHED ASSY (CASE) |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2010-08-06 |
| Model Number | NA |
| Catalog Number | 0500145A |
| Lot Number | 10AU03015 |
| ID Number | NA |
| Device Expiration Date | 2013-01-01 |
| 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 | 2010-08-06 |