FDA Adverse Event
Other
Summary report: N
AQUALINE AQUARIUS SYSTEM DISPOSABLE SET
MDR report key: 1242531
·
Received November 19, 2008
Report
- Report Number
- 6000002-2008-09319
- Event Type
- Other
- Date Received
- November 19, 2008
- Date of Event
- October 25, 2008
- Report Date
- October 28, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, DUE TO THE PRE-FILTER HIGH PRESSURE ALARM, THE USER DISCONNECTED THE PREFILTER CLAMP TO CHECK IT AND CONNECTED IT AGAIN. THE MACHINE RESTARTED, BUT 5 MINUTES LATER, THE HIGH PRESSURE ALARMS WENT OFF AGAIN, AND BLOOD BURST OUT WITH BLOOD PROJECTIONS ALL AROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUALINE AQUARIUS SYSTEM DISPOSABLE SET | DISPOSABLE LINE SET | DWF | EDWARDS LIFESCIENCES | AQUALINE | NO7168/NO7102/NO826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |