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.
[604265]
The nurse reported an empty pbp bag and a full effluent bag nearly at the same time. As she tried to change the pbp (pre blood pump) bag, she saw an alarm "effluent bag empty" and it was impossible for her to change into the pbp screen. The treatment was stopped. Reported machine runtime 2300 (h). No blood loss reported.
Patient Sequence No: 1, Text Type: D, B5
[7927788]
No pt injury or medical intervention was reported. No blood loss was reported. The data files have been reviewed by the manufacturer and further questions put to the user site. The manufacturing site will conduct further investigation. A follow up report will be submitted as soon the investigation has been concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00327 |
| MDR Report Key | 809654 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-27 |
| Date of Report | 2006-09-27 |
| Date of Event | 2006-09-21 |
| Date Mfgr Received | 2006-09-27 |
| Device Manufacturer Date | 2005-01-01 |
| 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, 10 |
| Manufacturer City | 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 | Y |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 797163 |
| 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 |