FDA Adverse Event
Malfunction
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3103305
·
Received May 9, 2013
Report
- Report Number
- 1416980-2013-11876
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT AT HOME GUIDE INSTRUCTS THE USE TO CLOSE THE TRANSFER SET WHEN THERAPY IS ENDED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HE DID NOT CLOSE HIS TRANSFER SET PROPERLY, AND SOLUTION HAS LEAKED OUT OF IT. THE TECHNICAL SERVICES REPRESENTATIVE ADVISED THE PATIENT TO CONTACT HIS NURSE REGARDING THE INCIDENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204366 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |