FDA Adverse Event
Malfunction
Summary report: N
VASO VIEW HEMOPRO
MDR report key: 4173192
·
Received October 10, 2014
Report
- Report Number
- 2242352-2014-01079
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 12, 2014
- Report Date
- September 15, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL COMPLAINT NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHEN THEY PLUGGED THE CORD INTO THE VASO VIEW HEMOPRO REMAINED ACTIVATED AND STARTED GLOWING RED. THEY REPLACED THE CABLE AND DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643091 | VASO VIEW HEMOPRO | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3000 | 25097345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |