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.
[20618151]
Customer reported an incident where there was a discrepancy between blood flow rate entered and status screen reading. No blood loss reported. Reported machine runtime was 93 (h).
Patient Sequence No: 1, Text Type: D, B5
[20804884]
No pt injury or medical intervention was reported. A gambro technical services (gts) representative evaluated the machine and checked the blood pump flow at several speeds and could not duplicate the reported problem. Primed the tubing set and performed a simulated run with no problems. Entered several different speeds for blood pump and status screen which read correctly. Additional information relating to this incident has been requested and further investigation of the incident will be conducted by the manufacturer. A 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 | 9616026-2006-00363 |
| MDR Report Key | 809685 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-27 |
| Date of Report | 2006-09-27 |
| Date of Event | 2006-09-27 |
| Date Facility Aware | 2006-09-27 |
| Report Date | 2006-09-27 |
| Date Reported to Mfgr | 2006-09-27 |
| Date Mfgr Received | 2006-09-27 |
| Device Manufacturer Date | 2004-12-01 |
| 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 | 3 |
| 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 | 797194 |
| 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 |