FDA Adverse Event
Malfunction
Summary report: N
ANTECARDIOPLEGIA KIT
MDR report key: 909471
·
Received September 6, 2007
Report
- Report Number
- 6000002-2007-52070
- Event Type
- Malfunction
- Date Received
- September 6, 2007
- Date of Event
- June 19, 2007
- Report Date
- June 19, 2007
- Manufacturer
- EDWARDS LIFESCIENCES RESEARCH MEDICAL
- 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, BLOOD LEAKAGE WAS OBSERVED DURING USE AT THE CONNECTION BETWEEN CONNECTOR AND THE TUBE OF THE ANTECARDIOPLEGIC SOLUTION INJECTATE LINE BEFORE CUSTOMER STARTED EXTRACORPOREAL CIRCULATION. NO PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTECARDIOPLEGIA KIT | ANTECARDIOPLEGIA KIT | DWF | EDWARDS LIFESCIENCES RESEARCH MEDICAL | RMI001 | 58286516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |