FDA Adverse Event
Death
Summary report: N
PD DISPOSABLES
MDR report key: 3718296
·
Received April 1, 2014
Report
- Report Number
- 1416980-2014-10642
- Event Type
- Death
- Date Received
- April 1, 2014
- Date of Event
- September 15, 2013
- Report Date
- March 7, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PT WAS NOT HOSPITALIZED PRIOR TO 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 |
|---|---|---|---|---|---|---|---|
| 194212 | PD DISPOSABLES | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | DIANEAL PD2 1.5%| DIANEAL PD2 4.25% |