FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3001904
·
Received March 13, 2013
Report
- Report Number
- 1416980-2013-05981
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(6). THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD A SYSTEM ERROR (SE) 2367 DURING PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS CONNECTED IN DWELL 1. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND INFORMED THE HOME PATIENT (HP) TO DISCONNECT AND USE MANUAL BAGS. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106027 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |