FDA Adverse Event
Malfunction
Summary report: N
VASO VIEW HEMOPRO
MDR report key: 2980085
·
Received February 21, 2013
Report
- Report Number
- 2242352-2013-00115
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 25, 2013
- Report Date
- January 28, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SILICONE TIP ON THE HEMOPRO JAW BROKE OFF DURING THE INSERTION INTO THE CANNULA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75086 | VASO VIEW HEMOPRO | ENDOSCPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR | VH-3000 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |