FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3090714
·
Received May 2, 2013
Report
- Report Number
- 1416980-2013-11177
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 10, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS TREATED WITH INTRAPERITONEAL INJECTIONS OF VANCOMYCIN, 1 GRAM EVERY 5TH DAY, REFLIN 1GRAM (IN ONE BAG, FREQUENCY NOT REPORTED) AND HEPARIN 1000 INTERNATIONAL UNITS (IU) (EACH BAG, FREQUENCY NOT REPORTED). THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. THE EVENT OF PERITONITIS WAS RESOLVING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192171 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | DIANEAL 2.5% ULTRABAG |