FDA Adverse Event
Death
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3760211
·
Received April 18, 2014
Report
- Report Number
- 1416980-2014-12733
- Event Type
- Death
- Date Received
- April 18, 2014
- Report Date
- March 26, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: (B)(4). ADDITIONAL INFORMATION: THE PATIENT WAS BORN ON AN UNREPORTED DATE IN (B)(6). THE PATIENT PASSED AWAY ON AN UNREPORTED DATE IN 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). 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 (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY DUE TO AN UNKNOWN CAUSE. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237142 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | DIANEAL PD4 1.5%| DIANEAL PD4 2.5%| DIANEAL PD2 1.5%| DIANEAL PD2 2.5% |