FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PROAUTOMATED PD
MDR report key: 3961858
·
Received July 28, 2014
Report
- Report Number
- 1416980-2014-24499
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 3, 2014
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THE REPORTED ISSUE WAS A DUPLICATE REPORT ADDRESS IN (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 A HOMECHOICE (HC) PRO EXPERIENCED AN UNSPECIFIED ALARM. THIS WAS OBSERVED BY THE PATIENT AND OCCURRED BEFORE USE IN THERAPY, ON THE DAY THAT THE PATIENT RECEIVED THE DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439421 | HOMECHOICE PROAUTOMATED PD | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |