MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,06 report with the FDA on 2010-09-29 for F6 DIALYZER FINISHED ASSY (CASE) 0500145A manufactured by Odgen Mfg..
[1838471]
We have received a report indicating that a home hemodialysis pt had "blood leak" during treatment. It was verified by the pt's mother that there was an internal blood leak that occurred. At that time, no add'l info was provided on the event. However, after speaking with the rn on (b)(6) 2010 it was learned that the pt is a (b)(6) medically fragile pt. Currently this pt continues hemodialysis with the use of this product. Samples are available for an eval.
Patient Sequence No: 1, Text Type: D, B5
[8766146]
Add'l info regarding the event was received on (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2010-00036 |
| MDR Report Key | 1865259 |
| Report Source | 00,04,05,06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-08-10 |
| Report Date | 2010-09-29 |
| Date Reported to Mfgr | 2010-08-16 |
| Date Mfgr Received | 2010-09-02 |
| 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 | 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 | F6 DIALYZER FINISHED ASSY (CASE) |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2010-09-29 |
| Model Number | NA |
| Catalog Number | 0500145A |
| Lot Number | 10AU03015 |
| ID Number | NA |
| Device Expiration Date | 2013-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ODGEN MFG. |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |