MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-09-08 for * manufactured by Gambro Lundia Ab, Monitor Div..
[22115438]
The technical data files with info about the treatment are not available according to the hosp's biomedical techs. The prismaflex machine was inspected by the hosp's biomed techs and it was found to be operating within the mfr's specs. It was authorized to be returned to clinical use on july 11. This event is being reported as per gambro policy: all cases of pt's death within 24 hrs of treatment are considered reportable regardless of any involvement of a gambro device. Gambro has found no evidence to suggest that its device caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2008-00010 |
| MDR Report Key | 1173783 |
| Report Source | 01,05,06 |
| Date Received | 2008-09-08 |
| Date Mfgr Received | 2008-07-09 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2008-09-26 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MIKAEL HENNINGSSON |
| Manufacturer Street | BOX 10101 |
| Manufacturer City | LUND SE-22010 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-22010 |
| Manufacturer Phone | 6169000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | MQS |
| Date Received | 2008-09-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1200240 |
| Manufacturer | GAMBRO LUNDIA AB, MONITOR DIV. |
| Manufacturer Address | MAGESTRATVAGEN 16 LUND SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-08 |