FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 3212826
·
Received July 9, 2013
Report
- Report Number
- 1416980-2013-17804
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- April 16, 2013
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME (HIGH DRAIN ERROR 107) EVENT WAS IDENTIFIED. THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A HIGH DRAIN ERROR 107 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. A HIGH DRAIN ALARM IS INDICATIVE OF AN IIPV SITUATION. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE ALARM OCCURRED ON (B)(6) 2013 10:22:13 DURING THE NIGHT DRAIN CYCLE SEVEN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313637 | HOMECHOICE PRO | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |