FDA Adverse Event
Malfunction
Summary report: N
HEMOPRO2 EXTENSION CABLE
MDR report key: 3810962
·
Received March 23, 2014
Report
- Report Number
- 2242352-2014-00312
- Event Type
- Malfunction
- Date Received
- March 23, 2014
- Date of Event
- February 25, 2014
- Report Date
- February 25, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. 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 PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CORD DID NOT PROVIDE ENOUGH POWER; THE CAUTERY WASN'T BURNING ENOUGH. THE HOSP DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171255 | HEMOPRO2 EXTENSION CABLE | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC. | VH-4030 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |