FDA Adverse Event
Malfunction
Summary report: N
ICY FEMORAL CATHETER 3893
MDR report key: 2977840
·
Received January 25, 2013
Report
- Report Number
- 3003793491-2013-00035
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- August 24, 2012
- Report Date
- October 18, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- LFK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36712 | ICY FEMORAL CATHETER 3893 | FEMORAL CATHETER | LFK | ZOLL CIRCULATION, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |