FDA Adverse Event
Death
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3771219
·
Received April 24, 2014
Report
- Report Number
- 1416980-2014-13245
- Event Type
- Death
- Date Received
- April 24, 2014
- Date of Event
- February 28, 2014
- Report Date
- March 31, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
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). AS THE SAMPLE WAS NOT RETURNED AND THE LOT 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 PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED OR IF DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250214 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | DIANEAL LOW CALCIUM 1.5% AND 2.5% DEXTROSE |