MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-30 for F3 DIALYZER FINISHED ASSY 050-87212 manufactured by Odgen Manufacturing.
[1759908]
An initial report was received reporting a blood leak right away. The facility was contacted for add'l info on this incident. It was learned that upon initiation of the dialysis treatment, gross blood was noted in the dialysate hose. It was confirmed that the event was an internal dialyzer leak. The reported blood loss was 101 ml. The pt had a stat h and h drawn. A new dialyzer was used to complete the treatment without further incident. There is no sample. The child was discharged to home when the treatment was complete. There is no further info that was reported regarding this incident.
Patient Sequence No: 1, Text Type: D, B5
[8824982]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2010-00050 |
| MDR Report Key | 1931951 |
| Report Source | 05,06 |
| Date Received | 2010-11-30 |
| Date of Report | 2010-11-30 |
| Date of Event | 2010-10-29 |
| Date Facility Aware | 2010-10-28 |
| Report Date | 2010-11-30 |
| Date Reported to Mfgr | 2010-11-01 |
| Date Mfgr Received | 2010-11-01 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-01-18 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F3 DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2010-11-30 |
| Model Number | NA |
| Catalog Number | 050-87212 |
| Lot Number | 09AU0423 |
| ID Number | NA |
| Device Expiration Date | 2012-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ODGEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-30 |