FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3181124
·
Received June 21, 2013
Report
- Report Number
- 1416980-2013-16074
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) AND A SUBSEQUENT SE 2367 (FAIL SAFE SHUT DOWN) ALARM. THIS OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE CAREGIVER (CG) CONTACTED BAXTER TECHNICAL SERVICE AND WAS ADVISED TO START THERAPY OVER WITH ALL NEW SUPPLIES. THE CG WAS ALSO INSTRUCTED TO INFORM THE PATIENT'S REGISTERED NURSE (RN) OF THE SE 2240. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283225 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | HOMECHOICE |