FDA Adverse Event
Death
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3930187
·
Received July 11, 2014
Report
- Report Number
- 1416980-2014-22407
- Event Type
- Death
- Date Received
- July 11, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- BAXTER HEATHCARE CORPORATION
- Product Code
- FKX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 UNKNOWN. PD THERAPY WAS ONGOING HOWEVER THE PATIENT WAS NOT CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406443 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEATHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death | DIANEAL 1.5% ULTRABAG PD4 SOLUTION |