FDA Adverse Event Malfunction Summary report: N

EOPA 3D VENTED ARTERIAL CANNULA

MDR report key: 3843517 · Received June 2, 2014

Report

Report Number: 2184009-2014-00039
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: November 5, 2013
Report Date: June 2, 2014
Manufacturer: PERFUSION SYSTEMS
Product Code: DWF
PMA / PMN Number: K061254
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ND, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION CONFIRMED THAT THE CANNULA BODY HAD SPLIT. THE DEVICE WAS OBSERVED UNDER MAGNIFICATION AND REVEALED AN EXPOSED WIRE. THERE WAS NO OUTWARD DAMAGE OR DIMENSIONAL ISSUE FOUND TO INDICATE A MANUFACTURING DEFECT WAS PRESENT. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. MEDTRONIC HAS INITIATED A FORMAL INVESTIGATION INTO RECENT EVENTS INVOLVING DAMAGE TO THE OUTER LUMEN OF CANNULAE. (B)(4).

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT AFTER USE OF THIS CANNULA IN A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE SURGEON NOTED THAT THE WIRE IN THE CANNULA BODY WAS EXPOSED IN THE AREA WHERE THE SILK SUTURE TIE WAS WRAPPED AROUND THE CANNULA TO SECURE THE CANNULA. THE CANNULA DID NOT LEAK, AND WAS USED FOR THE ENTIRE PROCEDURE. THE EXPOSED WIRE WAS NOTICED AFTER THE PATIENT WAS WEANED OFF OF CPB. THE SURGEON ELECTED TO REPLACE THE CANNULA IN CASE THE PATIENT HAD TO GO BACK ON CPB. THERE WAS NO IMPACT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321970	EOPA 3D VENTED ARTERIAL CANNULA	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	DWF	PERFUSION SYSTEMS	78220	2013060361

Patients

Seq	Age	Sex	Outcome	Treatment
1