FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3250296
·
Received July 26, 2013
Report
- Report Number
- 1416980-2013-19879
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Date of Event
- November 18, 2012
- Report Date
- July 2, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- 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.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 ALARM (AIR IN SET) WAS IDENTIFIED IN THE LOG WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED ON (B)(6) 2012 07:53:58. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350197 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |