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.
[604137]
Customer reported a discrepancy between the set flow rate and the true flow rate on the replacement pump, which resulted in a wrong replacement weight loss and a wrong effluent weight. No blood loss reported. Reported machine runtime 1946 (h).
Patient Sequence No: 1, Text Type: D, B5
[7824123]
No pt injury or medical intervention was reported. No blood loss was reported. The data files have been received and reviewed. Initial investigation suggests that this is a case of flow-rate discrepancy. The manufacturing site is conducting further investigation. A follow-up report will be provided on conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00329 |
| MDR Report Key | 809640 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-27 |
| Date of Report | 2006-09-28 |
| Date of Event | 2006-09-28 |
| Device Manufacturer Date | 2004-10-01 |
| 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 | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 797149 |
| 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 |