FDA Adverse Event Summary report: N

CARDINAL CAREFUSION IV POLE WITH RAKE TOP

MDR report key: 2231419 · Received August 29, 2011

Report

Report Number
2231419
Date Received
August 29, 2011
Report Date
August 29, 2011
Manufacturer
CAREFUSION
Product Code
FOX
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE STAFF REPORTED THEY ARE CONCERNED ABOUT THE DESIGN OF THE IV POLE, SPECIFICALLY WITH REGARD TO THE RAKE-TOP AT THE PEAK OF THE POLE. THE DESIGN IS A RAKE-TOP THAT HAS ONE SIDE OF THE RAKE HOOKS ELEVATED AND THE OPPOSITE SIDE DROPPED DOWN APPROXIMATELY 6 INCHES. THE ENDS OF ALL OF THE HOOKS ARE BLUNT, BUT THE DESIGN OF THE RAKE TOP ALLOWS FOR THE LOWER SET OF HOOKS TO BE AT EYE LEVEL WHILE THE OTHER HALF ARE ABOVE THE EYES. THE STAFF IS CONCERNED THAT PATIENTS, VISITORS AND STAFF MEMBERS COULD BE INJURED IF THE RAKE HOOKS COME IN CONTACT WITH THEIR EYES. ALTHOUGH ONE STAFF MEMBER IN RADIOLOGY REPORTED THAT WHEN HE TURNED HIS HEAD, HIS GLASSES BECAME SNAGGED ON THE RAKE HOOK AND CAME OFF OF HIS FACE, NO INJURIES HAVE OCCURRED AT OUR FACILITY. WE DISCUSSED THIS DESIGN FEATURE AND THE STAFF CONCERNS AND EXPERIENCES WITH THE MANUFACTURER. PER THE MANUFACTURER, THEY ARE NOT AWARE OF ANY INJURY REPORTS WITH THIS DEVICE. THE STAFF SUGGESTED THAT THE MANUFACTURER COULD IMPROVE THE SAFETY OF THE DEVICE BY PLACING ROUNDED RUBBER TIPS ON THE ENDS OF THE RAKE HOOKS. THE RAKE TOP ITSELF IS MADE BY PRYOR PRODUCTS (CATALOG NUMBER1090A), BUT IS SOLD TO CAREFUSION (CARDINAL HEALTH) FOR USE ON THEIR IV POLE. WE ALSO CONTACTED PRIOR TO SHARE THE ABOVE AND WE WERE TOLD THAT THERE HAVE BEEN NO ISSUES OR SAFETY INCIDENTS WITH THE DEVICE. PRYOR INFORMED US THAT THEY ONLY MANUFACTURE THE RAKE TOP, WHICH IS THEN SOLD TO CARDINAL.======================MANUFACTURER RESPONSE FOR HEX BASED SINGLE IV POLE W/RAKE TOP, CARDINAL (CAREFUSION) IV POLE WITH RAKE TOP (PER SITE REPORTER)======================CAREFUSION CUSTOMER ADVOCACY REPRESENTATIVE WAS NOTIFIED OF THIS CONCERN. WE HAVE HAD NO FURTHER FOLLOW UP FROM THE MANUFACTURER REGARDING THIS REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARDINAL CAREFUSION IV POLE WITH RAKE TOP HEX BASED SINGLE IV POLE W/RAKE TOP FOX CAREFUSION 901-CAS-1151 *

Patients

Seq Age Sex Outcome Treatment
1 *