MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-04 for PHOENIX * manufactured by Gambro Renal Products, Inc..
[445891]
Unit shut down all operations, including blood pump (therefore, patient's blood had to be manually pumped back into patient before patient could be placed on another machine) due to the machine going in to a "general safestate condition". This was due to a communication timeout within the electronics of the machine. The first response (from gambro) to the issue was to use a substance called stabilant 22, which was supposed to clean the contacts on connector j37. The next response to the issue was to replace the j37 harness on all three machines. The most recent response to the issue has been to replace the '5 volt' power supply, that has an older style transformer, with a new power supply that has an older style transformer, because the newer 'switching' style power supply cannot be used on these older machines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 712397 |
| MDR Report Key | 712397 |
| Date Received | 2006-05-04 |
| Date of Report | 2006-05-04 |
| Date of Event | 2006-04-11 |
| Report Date | 2006-05-04 |
| Date Reported to FDA | 2006-05-04 |
| Date Added to Maude | 2006-05-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOENIX |
| Generic Name | DIALYSIS MACHINE |
| Product Code | KPF |
| Date Received | 2006-05-04 |
| Model Number | PHOENIX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 701453 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-04 |