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 2006-09-14 for PRISMAFLEX SYSTEM 6023014700 manufactured by Gambro Lundia Ab, Monitor Div..
[657756]
Customer reported a 90 ml flow discrepancy in pt fluid removal. When user set fluid removal at 100 ml, 190 ml was removed. (100 ml at "set flow rate" and on status screen 190 ml. ) set flow: bloodflow 250 ml/min, pbp 1000 ml/h, dialysate 1000 ml/h, replacement post 250 ml/h. This was discovered after 24 hours of treatment.
Patient Sequence No: 1, Text Type: D, B5
[7815410]
No pt injury or medical intervention was reported. Gambro renal products has requested the downloaded machine data files and add'l info relating to this incident. A final report will be submitted once corrective action has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00297 |
| MDR Report Key | 879190 |
| Report Source | 01,05,06 |
| Date Received | 2006-09-14 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-08-14 |
| Date Mfgr Received | 2006-08-15 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2007-07-12 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANDERS EDNER |
| Manufacturer Street | BOX 10101 |
| Manufacturer City | LUND SE-220 10 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-220 10 |
| Manufacturer Phone | 6169069 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX SYSTEM |
| Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Product Code | KPF |
| Date Received | 2006-09-14 |
| Model Number | 6023014700 |
| Catalog Number | 6023014700 |
| Lot Number | NA |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 858447 |
| Manufacturer | GAMBRO LUNDIA AB, MONITOR DIV. |
| Manufacturer Address | BOX 10101 LUND SW SE-220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-14 |