FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3232812
·
Received July 18, 2013
Report
- Report Number
- 1416980-2013-18812
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- July 23, 2012
- Report Date
- June 23, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG IDENTIFIED THE IIPV EVENT. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED, WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2012 AT 10:26:16. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 243ML, INDICATING THE HOME PATIENT (HP) DRAINED 243ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335054 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |