FDA Adverse Event
Death
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3140801
·
Received May 31, 2013
Report
- Report Number
- 1416980-2013-13970
- Event Type
- Death
- Date Received
- May 31, 2013
- Date of Event
- September 9, 2011
- Report Date
- September 10, 2011
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD BEEN HOSPITALIZED AND PASSED AWAY DUE TO A BLOOD STREAM INFECTION. THE CAUSE WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242321 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death| H | DIANEAL AND HOME CHOICE |