FDA Adverse Event
Malfunction
Summary report: N
FRESENIUS NXSTAGE CONTROL UNIT NX2000-1
MDR report key: 14374647
·
Received May 11, 2022
Report
- Report Number
- MW5109641
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Date of Event
- December 23, 2021
- Report Date
- March 24, 2022
- Manufacturer
- NXSTAGE MEDICAL, INC.
- Product Code
- FKR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT'S CONTROL UNIT SWAPPED UNABLE TO PRIME PAK NXSTAGE TECH SUPPORT CAN'T CORRECT, SWAP PROMPTED. ON (B)(6) 2021 PT RECEIVED NEW CONTROL UNIT CAN'T COMPLETE SAK, TECH SUPPORT UNABLE TO RESOLVE, NEW CONTROL UNIT ARRIVED (B)(6) 2022. PT HAD BACKUP TX AT UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2382283 | FRESENIUS NXSTAGE CONTROL UNIT NX2000-1 | SUBSYSTEM, PROPORTIONING | FKR | NXSTAGE MEDICAL, INC. | NX2000-1 | ||
| 2382284 | FRESENIUS NXSTAGE CONTROL UNIT NX2000-1 | SUBSYSTEM, PROPORTIONING | FKR | NXSTAGE MEDICAL, INC. | NX2000-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Other |