FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2 EVH SYSTEM
MDR report key: 2121933
·
Received May 23, 2011
Report
- Report Number
- 2242352-2011-00500
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 28, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 HEATING ELEMENT WOULD NOT TURN ON. THIS OCCURRED INSIDE THE PT. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO 2 EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH-4000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |