FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 4233760
·
Received November 6, 2014
Report
- Report Number
- 1416980-2014-39205
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 12, 2014
- Report Date
- October 12, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE PATIENT LINE OF THE CASSETTE EITHER BECAME DISCONNECTED OR WAS NEVER THERE. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING USE ON THE HOMECHOICE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE CAREGIVER TO START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714605 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME | H14118106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | HOMECHOICE |