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

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.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,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 Key: 7742322
• MDR Text Key: 115796520
• Report Number: 3009211636-2018-00260
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521005157
• UDI-Public: 20884521005157
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8830415001
• Device Catalogue Number: 8830415001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death