FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 4130434
·
Received September 30, 2014
Report
- Report Number
- 1416980-2014-33929
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 5, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SYSTEM ERROR 2367 (POWER FAILURE ERROR THAT DISCONTINUES THE PRESENT THERAPY AND IS DUE TO A POSSIBLE AIR IN SET/LINE) ALARM OCCURRED ON A HOMECHOICE DEVICE DURING PERITONEAL DIALYSIS THERAPY. THE POWER WAS CYCLED TO CLEAR THE ALARM AND THE PATIENT WAS ADVISED TO CONTACT THEIR NURSE REGARDING THE EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608563 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | HOMECHOICE |