FDA Adverse Event
Death
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3815534
·
Received May 16, 2014
Report
- Report Number
- 1416980-2014-15828
- Event Type
- Death
- Date Received
- May 16, 2014
- Report Date
- April 23, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. 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
THIS IS A REPORT OF A PATIENT WHO PASSED AWAY COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. IT WAS UNKNOWN IF THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294507 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |