FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 4121841
·
Received September 26, 2014
Report
- Report Number
- 1416980-2014-33384
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- August 6, 2014
- Report Date
- September 2, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND EVALUATED. THIS IS AN ANCILLARY SERVICE EVENT. A REVIEW OF THE ALARM LOG IDENTIFIED THE OCCURRENCE OF A HIGH DRAIN ERROR 101 ALARM. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 (NIGHT DRAIN 1) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2014 15:30:35. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601620 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |