ICY FEMORAL CATHETER 3893
Received Jan 25, 2013 · Event occurred Aug 24, 2012
Report 3003793491-2013-00035 · MDR key 2977840
Device
Generic name
Femoral Catheter
Manufacturer
Zoll Circulation, Inc.Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Cardiac Arrest
- Death
- Unspecified Infection
- Staphylococcus Aureus
- Alteration In Body Temperature
Narrative
Additional Manufacturer Narrative
ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED.
Description of Event or Problem
CUSTOMER REPORTED THAT "CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION ON 3 SEPARATE OCCASIONS". EVENT 3: IT WAS REPORTED THAT ON (B)(6) 2012, ICY FEMORAL CATHETER WAS PLACED FOR A CARDIAC ARREST PATIENT. THE CATHETER WAS REMOVED ON (B)(6) /2012 DUE TO PATIENT'S INCREASE IN TEMPERATURE. ICY CATHETER'S TIP WAS CULTURED, STAPH AUREUS BACTERIA WAS IDENTIFIED. PATIENT EXPIRED ON (B)(6) 2012. EVENT 1: MFR REPORT# 3003793491-2013-00033, EVENT 1: MFR REPORT# 3003793491-2013-00034, EVENT 1: MFR REPORT# 3003793491-2013-00035.