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..
[604530]
The customer reported, during treatment, when changing the pbp flow rate the rn entered rated (190ml/hr) pressed the enter button but this was not the same rate showing on the status screen, the status screen showed 180ml/hr. After several attempts to re-enter the pbp flow rate. No blood loss reported. Reported machine runtime > 1000(h).
Patient Sequence No: 1, Text Type: D, B5
[7939211]
No patient injury or medical intervention was reported. A gambro technical services (gts) representative was contacted. The rate on the 'flow rate' screen and the 'status' screen were now correlating. The downloaded machine data files have been requested. Further investigation is ongoing. A follow-up or final report will be submitted once the investigation has been completed and corrective action has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00342 |
| MDR Report Key | 810173 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-30 |
| Date of Report | 2006-09-30 |
| Date of Event | 2006-09-30 |
| Date Mfgr Received | 2006-09-30 |
| Device Manufacturer Date | 2005-12-01 |
| 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 | 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 | 2006-10-30 |
| Model Number | 6023014700 |
| Catalog Number | 6023014700 |
| Lot Number | NA |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 797657 |
| 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 |