FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3171747
·
Received June 16, 2013
Report
- Report Number
- 1416980-2013-15479
- Event Type
- Malfunction
- Date Received
- June 16, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS UNAVAILABLE, THEREFORE NO EVALUATION COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM. THIS HAD OCCURRED ON THE HOMECHOICE (HC) MACHINE, DURING THE DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP TO CLEAR THE ERROR AND INFORMED THE HP OF THE ERROR'S MEANING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272760 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | HOMECHOICE |