FDA Adverse Event Malfunction Summary report: N

VASOVIEW HEMOPRO

MDR report key: 19483755 · Received June 7, 2024

Report

Report Number
19483755
Event Type
Malfunction
Date Received
June 7, 2024
Date of Event
May 6, 2024
Report Date
May 13, 2024
Manufacturer
MAQUET CARDIOVASCULAR LLC
Product Code
GEI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

VASOVIEW HEMOPRO DISPOSABLE KIT ISSUE. PA REPORTED THAT THE VASOVIEW BISECTOR SHE USED WAS NOT COMING OUT OF THE DEVICE IN THE USUAL FASHION AND PART OF THE DEVICE WHICH IS SUPPOSED TO RETRACT BACK INTO THE DEVICE ALL THE WAY WAS NOT DOING SO. PER PA WHO DOES CABG (CORONARY ARTERY BYPASS GRAFT SURGERY) VEIN HARVESTS ROUTINELY, AFTER USING THE DISPOSABLE KIT USED TODAY IT WAS NOT WORKING THE WAY OTHER KITS HAVE WORKED. SHE REQUESTED THAT WE SEND KIT BACK TO MANUFACTURER. THE KIT IS REF# VH-3000, LOT# 3000379282, EXP. DATE [REDACTED DATE], MANUFACTURED BY MAQUET CARDIOVASCULAR LLC/ GETINGE. THIS AUTHOR PUT THE USED DISPOSABLE VASOVIEW IN A PLASTIC BAG AND BACK INTO THE BOX IT CAME IN, LABELED WITH A PT STICKER AND A WRITTEN EXPLANATION ON THE OUTSIDE OF THE BOX AS TO THE PROBLEM. CLINICAL SITE CORRESPONDS DIRECTLY WITH THE MANUFACTURER REP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1285820 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-3000 3000379282

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown