FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3162894
·
Received June 11, 2013
Report
- Report Number
- 1416980-2013-14999
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- May 20, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS IN THE DEVICE. A SAMPLE THERAPY WAS PERFORMED USING THE CASSETTE AND REVEALED NO LEAKS OR DEFECTS. THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED DURING TESTING. THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN AUTOMATED PD SET WITH CASSETTE WAS LEAKING FROM THE BLUE PRESSURE PAD. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262070 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |