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 2006-10-27 for PRISMAFLEX SYSTEM 6023014700 manufactured by Gambro Lundia Ab, Monitor Division.
[581914]
The client reported a blood flow rate ordered at 130ml/min. The status screen displayed 130ml/min and the flow rate screen displayed the blood flow rate at 110. The flow rate screen was changed to 130, and the status screen displayed 150. The blood flow rate was decreased to 10ml/min, then brought back up to the correct setting which fixed the flow rate issue. The flow rate screen and the status screen both displayed 130 for the blood flow rate. The pt remains on the flex, so no pt data was provided. Reported machine runtime greater than 400 (h).
Patient Sequence No: 1, Text Type: D, B5
[7927793]
No pt injury or medical intervention was reported. The manufacturer is aware of this machine malfunction and is working on corrections. A follow-up report will be provided on conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00339 |
| MDR Report Key | 809670 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-27 |
| Date of Report | 2006-09-29 |
| Date of Event | 2006-09-20 |
| Date Mfgr Received | 2006-09-29 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-01-30 |
| 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 | 10 LUND SE-220 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-220 |
| 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 | 2006-10-27 |
| Model Number | 6023014700 |
| Catalog Number | 6023014700 |
| Lot Number | NA |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 797179 |
| Manufacturer | GAMBRO LUNDIA AB, MONITOR DIVISION |
| Manufacturer Address | BOX 10101, 10 LUND SW SE-220 |
| 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 | 2006-10-27 |