• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALSIUS START UP KIT CATHETER KIT 12011

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALSIUS START UP KIT CATHETER KIT 12011 Back to Search Results
Model Number 424164
Device Problems Air Leak (1008); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2016
Event Type  malfunction  
Event Description
Alsius line alarmed with air in the line error. Normal saline bag attached to alsius line almost empty. Line detached from pt and 200cc of fluid were displaced. New alsius system set up, attached to pt and no problems noted with the new system. The pt was not harmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTART UP KIT
Type of DeviceCATHETER KIT 12011
Manufacturer (Section D)
ALSIUS
newcastle, staffordshire ST59Q F
UK ST59QF
MDR Report Key5671063
MDR Text Key45771992
Report NumberMW5062411
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number424164
Device Catalogue Number8700-0657-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-