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

MAUDE Adverse Event Report: COVIDIEN MAHURKAR COVIDIEN MAHURKAR TUNNELED INTERNAL JUGULAR CATHETER; JUGULAR DIALYSIS

  • 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
 

COVIDIEN MAHURKAR COVIDIEN MAHURKAR TUNNELED INTERNAL JUGULAR CATHETER; JUGULAR DIALYSIS Back to Search Results
Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990)
Patient Problems Cardiopulmonary Arrest (1765); Exsanguination (1841); Blood Loss (2597)
Event Date 10/27/2018
Event Type  Death  
Event Description
Pt attended scheduled hemodialysis treatment.Pt was alert, calm and lethargic.Predialysis bp 162/78, pulse 69, temp 96.8, resp 17.Hemodialysis was initiated via right internal tunneled jugular catheter.At approx 1513 dialysis initiated.Within mins unable to achieve prescribed blood flow rate.The venous bloodline was then reversed and connected to the pt's arterial (red) catheter port and the arterial bloodline was connected to the pt's venous (blue) catheter port.The hemaclip was secured to the venous bloodline and the pt's arterial catheter port.Hemodialysis treatment was resumed, bp 176/78, pulse 69, blood flow rate at 350.At approx 1530 the pt was noted to have difficulty breathing, was pale in color, the pt's right fingers and side of shirt noted with blood.The venous bloodline and the pt's arterial (red) port had become disconnected with the hemaclip remaining in place.The pt's catheter ports were clamped, approx 750ml of normal saline administered, 911 and cpr initiated.Pt transported to er.Expired in er at approx 1616.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COVIDIEN MAHURKAR TUNNELED INTERNAL JUGULAR CATHETER
Type of Device
JUGULAR DIALYSIS
Manufacturer (Section D)
COVIDIEN MAHURKAR
minneapolis MN
MDR Report Key8077653
MDR Text Key127457726
Report Number8077653
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2018
Distributor Facility Aware Date10/27/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/08/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/14/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
1000ML NORMAL SALINE; F180NRE OPTIFLUX DIALYZER; FRESENIUS PRODUCT - 2008T MACHINE; GRANUFLO 3.0K, 2.0CA, 1.0MG, 100 DEXTROSE (G3201); HEMACLIP ; NATURALYTE SERIES 4000; TRUE FLOW COMBI SET BLOOD LINES
Patient Outcome(s) Death; Life Threatening;
Patient Age75 YR
Patient Weight44
-
-