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 2006-08-25 for manufactured by .
[7928852]
The patient did not suffer an injury nor require medical intervention for this blood loss. According to the final clinical report this pt is a long term chronic pt at this facility and has an established heparinization program. The clotting may have been due to the pt's high hemoglobin. No serial number of the machine was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616240-2006-00430 |
| MDR Report Key | 974537 |
| Report Source | 05,06,07 |
| Date Received | 2006-08-25 |
| Date Mfgr Received | 2006-07-26 |
| Date Added to Maude | 2008-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANCESCO BARDELLI |
| Manufacturer Street | VIA MODENESE, 66 |
| Manufacturer City | MEDOLLA (MO) I-41036 |
| Manufacturer Country | IT |
| Manufacturer Postal | I-41036 |
| Manufacturer Phone | 53550111 |
| Manufacturer G1 | GAMBRO DASCO |
| Manufacturer Street | VIA MODENESE, 66 |
| Manufacturer City | MEDOLLA (MO) I-41036 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | I-41036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KII |
| Date Received | 2006-08-25 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 942776 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-25 |