FDA Adverse Event
Malfunction
Summary report: N
EDWARDS AQUAMAX HF 12
MDR report key: 1375003
·
Received May 6, 2009
Report
- Report Number
- 2015691-2009-10485
- Event Type
- Malfunction
- Date Received
- May 6, 2009
- Date of Event
- April 9, 2009
- Report Date
- April 9, 2009
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- FKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INJURY OR DEATH WAS REPORTED. AT THE TIME OF THIS REPORT, NO PRODUCT WAS RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REPORTEDLY, CIRCUIT HAD BEEN IN USE WITH VASCATH APPROX 65 HOURS, WHEN TRYING TO DISCONNECT END OF CIRCUIT CAME AWAY AND REMAINED ATTATCHED TO VASCATH.VASCATH HAD TO BE REPLACED AS WELL AS CIRCUIT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS AQUAMAX HF 12 | HAEMOFILTER | FKJ | EDWARDS LIFESCIENCES | HF12 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |