FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3200182
·
Received July 1, 2013
Report
- Report Number
- 1416980-2013-16940
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- March 17, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED. HOWEVER, THE CAUSE OF THE HIGH DRAIN ALARM COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) DURING NIGHT DRAIN ONE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299547 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |