FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3212639
·
Received July 9, 2013
Report
- Report Number
- 1416980-2013-17797
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- July 19, 2012
- Report Date
- June 17, 2013
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2012, 15:43:16. DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 968ML, INDICATING THE HOME PATIENT (HP) DRAINED 968ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1300ML. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312401 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |