FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 4242106
·
Received November 10, 2014
Report
- Report Number
- 1416980-2014-39827
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 12, 2014
- Report Date
- October 13, 2014
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE HOMECHOICE (HC) DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW AND A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED EVENT COULD NOT BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
COMPLAINT NO: CMPLNT-(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED AN UNKNOWN ALARM. THIS OCCURRED DURING AN UNKNOWN STEP IN PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723053 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |