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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN MAHURKAR; HEMODIALYSIS DOUBLE-LUMEN CATHETER

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COVIDIEN LLC COVIDIEN MAHURKAR; HEMODIALYSIS DOUBLE-LUMEN CATHETER Back to Search Results
Model Number REF 8888135193
Device Problems Fluid/Blood Leak (1250); Component Missing (2306)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Exsanguination (1841); Weakness (2145); Loss of consciousness (2418); Confusion/ Disorientation (2553); Weight Changes (2607)
Event Date 01/05/2019
Event Type  Death  
Event Description
The patient, a (b)(6) male, had an extensive medical history that included: poor self-care, malnutrition, chronic kidney disease, chronic heart failure with pulmonary edema and moderate mitral regurgitation, severe peripheral vascular disease, chronic pain due to left lower-extremity (b)(6) wounds, a history of opiate dependence, metabolic encephalopathy, coronary artery disease, hypertension, recurrent c diff, (b)(6), and tobacco dependence.He was admitted on (b)(6) 2018 with failure to thrive, weakness, confusion, and progressive weight loss.Hemodialysis was initiated on (b)(6) 2018.At 0101 on (b)(6) 2019, the patient yelled out of his room, stating that he was bleeding.The rn found that the patient, ¿had pulled his [ij] hd catheter¿, though later it was revealed that the catheter remained fully inserted and sutured in place.Rrt was called.While the rn was holding pressure, the patient began agonal breathing and became unresponsive.A code blue was called, and at that time the patient was pulseless.Compressions and cpr were initiated, the patient was intubated, and acls protocol initiated.Swat rn, who was involved in the code, took over holding pressure on the neck, used his finger to clamp the right arm of the dialysis catheter, which was missing the hub and from which blood was spurting.The code was unsuccessful and the patient expired.
 
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Brand Name
COVIDIEN MAHURKAR
Type of Device
HEMODIALYSIS DOUBLE-LUMEN CATHETER
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire st
mansfield MA 02048
MDR Report Key8400651
MDR Text Key138146756
Report Number8400651
Device Sequence Number1
Product Code PPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberREF 8888135193
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2019
Distributor Facility Aware Date01/07/2019
Event Location Hospital
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
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight51
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