FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO EVH SYSTEM
MDR report key: 2093284
·
Received April 14, 2011
Report
- Report Number
- 2242352-2011-00344
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 16, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE KIT WAS REC'D WITH THE PACKAGING UNSEALED. A BALLPOINT PEN WAS FOUND IN THE TRAY, NEAR THE ACCESSORY TRAY. NO OTHER COMPONENTS WERE AFFECTED OR MISSING. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "FOREIGN OBJECT IN KIT" WAS CONFIRMED. A LOT HISTORY REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, A FOREIGN OBJECT WAS FOUND IN THE VH-3000 KIT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3000 | 25027130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |