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 2006-10-30 for PRISMAFLEX SYSTEM 6023014700 manufactured by Gambro Lundia Ab, Monitor Div..
[582181]
Customer reported at the flow rate screen he chose, patient fluid removal of 100 ml, then he goes to the status screen and it shows 80 ml instead of the 100 ml that he set. Customer was told to reboot machine to reboot the software if it did not work to switch to a different machine. No blood loss was reported.
Patient Sequence No: 1, Text Type: D, B5
[8056537]
No patient injury or medical intervention was reported. Gambro renal products has requested the downloaded machine data files and additional information relating to this incident. A final report will be submitted once the investigation is concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00330 |
| MDR Report Key | 810163 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-30 |
| Date of Report | 2006-09-30 |
| Date of Event | 2006-09-30 |
| Date Facility Aware | 2006-09-30 |
| Report Date | 2006-09-30 |
| Date Reported to Mfgr | 2006-09-30 |
| Date Mfgr Received | 2006-09-30 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2007-01-31 |
| 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 | 3 |
| 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 | 2006-10-30 |
| Model Number | 6023014700 |
| Catalog Number | 6023014700 |
| Lot Number | NA |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.4 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 797647 |
| Manufacturer | GAMBRO LUNDIA AB, MONITOR DIV. |
| Manufacturer Address | BOX 10101 LUND SW SE-220 10 |
| Baseline Brand Name | PRISMAFLEX SYSTEM |
| Baseline Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Baseline Model No | 6023014700 |
| Baseline Catalog No | 6023014700 |
| Baseline ID | SW 2.01 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-30 |