MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, RENAL THERAPIES COMBI-SET TRUE FLOW SERIES; HEMODIALYSIS BLOOD TUBING SET

Model Number 8 MM PUMP SEGMENT

Device Problems Failure To Adhere Or Bond (1031); Connection Problem (2900)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Exsanguination (1841); Hypovolemia (2243)

Event Date 10/17/2017

Event Type  Death  

Event Description

Approximately 1.5 hours into a scheduled 4 hour hemodialysis treatment, blood was noted on the floor on the right side of the patient's chair.The venous bloodline was detached from the venous lumen of the central venous catheter.The blood pump was stopped and lumen clamped.Patient was unresponsive.Oxygen and aed were applied and cpr initiated.Phone number 911 was called.Normal saline was infused via arterial line.Patient was transported to the hospital via ems, where she later expired.Rn reported that hemaclips were applied to both arterial and venous lines at initiation of treatment.

• Brand Name: COMBI-SET TRUE FLOW SERIES
• Type of Device: HEMODIALYSIS BLOOD TUBING SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, RENAL THERAPIES; waltham MA
• MDR Report Key: 7003071
• MDR Text Key: 91219386
• Report Number: 7003071
• Device Sequence Number: 1
• Product Code: ONW
• 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: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 8 MM PUMP SEGMENT
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17JR01224
• 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: 10/26/2017
• Distributor Facility Aware Date: 10/17/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/26/2017
• 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: 0
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 111