FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3140952
·
Received June 3, 2013
Report
- Report Number
- 1416980-2013-13983
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- April 30, 2013
- Report Date
- May 10, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DURING EVALUATION OF A HOMECHOICE HARDWARE DEVICE AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. THIS COMPLAINT IS RELATED TO (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem · 1
A SYSTEM ERROR 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2013 06:29:46. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244986 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |