FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 4102900
·
Received September 19, 2014
Report
- Report Number
- 1416980-2014-32347
- Event Type
- Injury
- Date Received
- September 19, 2014
- Report Date
- August 25, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER TRANSFER SET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED CLOUDY EFFLUENT AND SUSPECT PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. CAUSE WAS NOT REPORTED. THE PATIENT WAS TREATED WITH UNKNOWN MEDICATION (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE OUTCOME OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585254 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | MINICAP, TITANIUM ADAPTER, DIANEAL 2.5% AMBUFLEX |