MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA RTG FRESENIUS MEDICAL CARE HEMACLIP BLOODLINE CONNECTOR

Catalog Number 04-9100-1

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.

• Brand Name: FRESENIUS MEDICAL CARE HEMACLIP BLOODLINE CONNECTOR
• Type of Device: HEMACLIP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA RTG; waltham MA 02451
• MDR Report Key: 8077630
• MDR Text Key: 127455303
• Report Number: 8077630
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04-9100-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2018
• Distributor Facility Aware Date: 10/27/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 1000ML NORMAL SALINE; COMBI SET TRUE FLOW; COVIDIEN MAHURKAR TUNNELED INTERNAL JUGULAR CATHETER; F180NRE OPTIFLUX DIALYZER; FRESENIUS PRODUCTS-2008T MACHINE; GRANUFLO 3.0K, 2.0CA, 1.0MG, 100 DEXTROSE (G3201); NATURALYTE SERIES 4000
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 75 YR
• Patient Weight: 44