FDA Adverse Event Malfunction Summary report: N

VASOVIEW HEMOPRO 2

MDR report key: 3813511 · Received March 26, 2014

Report

Report Number: 2242352-2014-00327
Event Type: Malfunction
Date Received: March 26, 2014
Date of Event: February 25, 2014
Report Date: February 28, 2014
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: GEI
PMA / PMN Number: K101274
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY, EXTENSION AND ADAPTER CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. A POLYFUSE ELECTRICAL TEST WAS PERFORMED WITH A REFERENCE POWER SUPPLY, ADAPTER CABLE AND EXTENSION; THE POLYFUSE SUCCESSFULLY SHUT OFF POWER TO THE HEATER AFTER PROLONGED PERIODS OF TIME AND ACTIVATE AFTER 30 SECONDS COOL DOWN. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

Description of Event or Problem · 1

THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 DEVICE BURNED OUT; A PRE-CAUTERY TEST WAS PERFORMED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
176887	VASOVIEW HEMOPRO 2	ENDOSCOPIC VESSEL HARVESTING	GEI	MAQUET CARDIOVASCULAR, LLC	VH-4000	25091338

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR