FDA Adverse Event
Death
Summary report: N
LIBERTY CYCLER
MDR report key: 1840230
·
Received September 20, 2010
Report
- Report Number
- MW5017467
- Event Type
- Death
- Date Received
- September 20, 2010
- Date of Event
- August 3, 2010
- Report Date
- September 20, 2010
- Product Code
- FKX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RECALL. PT DIAGNOSED WITH PERITONITIS, SEPTIC INFECTION AND ULTIMATELY DIED. SOMETHING SHOULD HAVE BEEN DONE SOONER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER | PERITONEAL DIALYSIS CYCLER SET | FKX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death| O |