FDA Adverse Event
Death
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 4102834
·
Received September 19, 2014
Report
- Report Number
- 1416980-2014-32213
- Event Type
- Death
- Date Received
- September 19, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 25, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS PULMONARY EDEMA AND HEART FAILURE. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584000 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death | DIANEAL 1.5% AND 2.5% AMBUFLEX |