FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 4092561
·
Received September 16, 2014
Report
- Report Number
- 1416980-2014-31437
- Event Type
- Injury
- Date Received
- September 16, 2014
- Report Date
- August 19, 2014
- Manufacturer
- BAXTER HEALTHCARE - SWINFORD
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER TITANIUM ADAPTOR 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 PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT¿S OUTCOME WAS ALSO UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573143 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - SWINFORD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | TRANSFER SET, MINICAP, DIANEAL |