FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3012758
·
Received March 20, 2013
Report
- Report Number
- 1416980-2013-06679
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- December 28, 2012
- Report Date
- February 25, 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
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DURING THE 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.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 ALARM (AIR IN LINE) WAS IDENTIFIED IN THE LOG WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE.¿ THE ALARM OCCURRED ON (B)(6) 2012, AT 02:29:29. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115892 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | HOMECHOICE |