MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for PHOENIX 6023006700 103453 manufactured by Gambro Renal Products, Inc..
[184119516]
Machine would not pull fluid despite being in dialysis mode. I tried several times to reset the goal and time to no avail. Another nurse cam shortly after and was able to get things to start. Machine gave an error in the beginning of "in bypass too long", but i hadn't started treatment yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853332 |
| MDR Report Key | 9853332 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-10-31 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOENIX |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-19 |
| Model Number | 6023006700 |
| Catalog Number | 103453 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 1101 JETER AVENUE OPELIKA AL 36801 US 36801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |