FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 3223673
·
Received July 12, 2013
Report
- Report Number
- 1416980-2013-18184
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- May 16, 2013
- Report Date
- June 17, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, TWO INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS WERE IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2013 AT 14:21:51. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 406ML, INDICATING THE HOME PATIENT (HP) DRAINED 406ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323039 | HOMECHOICE PRO | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |