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

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

  • 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 MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8830415001
Device Problems Device Alarm System (1012); Break (1069); Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 07/12/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during dialysis treatment, the catheter had a luer adapter leak. The dialysis was performed using the patient's right jugular internal site while the machine was located on the left side of the patient. When connecting the lines, they needed to reverse the lines because the flow was too low that lead to an arterial pressure alarm. The lines were connected without issue. The connecting lines were protected by a sterile waterproof sheet. However, despite reversing the lines, several arterial pressure alarms led the nurses to re-launch the dialysis. A new alarm was heard and when the nurse went to check the machine, blood under the patient bed was discovered. When opening the sterile sheet, the nurse saw the bed full of blood and a leak could be observed between the junction of the valve and the venous line or between the catheter and the valve. An attempt to screw the line and to fill the patient was made. The doctor was called and saw the patient was dead.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key7742322
MDR Text Key115796520
Report Number3009211636-2018-00260
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8830415001
Device Catalogue Number8830415001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
-
-