MAUDE Adverse Event Report: MEDCOMP CATHETER, HEMODIALYSIS, IMPLANTED

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 10/17/2017

Event Type  Death  

Event Description

On (b)(6) 2017 approximately one and half hours into a scheduled four -hour hemodialysis (hd) treatment, blood was noted on the floor to the right of the patient's chair.This was observed during a random check by a staff member as the previous patient check at a unknown time was uneventful with no patient complaints or symptoms.The venous bloodline was detached from the venous lumen of the central venous catheter.No machine alarms were generated prior to, during, or following the patient incident.The blood pump was stopped and the lumen was clamped.The patient was unresponsive.The estimated blood loss (ebl) was reported to be between 100-300ml and the nurse stated that the patient became unresponsive due to blood loss.The staff administered oxygen, the automated external defibrillator (aed) was applied, cardiopulmonary resuscitation (cpr) was initiated, and 911 was called.Normal saline was infused via the patient's arterial line.The patient was transported to the hospital via emergency medical services (ems) and later expired.The hemoclips were applied to both arterial and venous lines at the initiation of the patient's treatment.The cause of death is stated as cardiopulmonary death and hypovolemia.It is unknown how the bloodline became disconnected from the catheter.There was no observed malfunction or defect with the products.Needle: medcomp central venous catheter, catalog # unknown, lot # unknown.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDCOMP
• MDR Report Key: 17533643
• MDR Text Key: 321041338
• Report Number: MW5140547
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1