MAUDE Adverse Event Report: FRESENIUS MEDICAL NORTH AMERICA COMBI SET TRUE FLOW SERIES HEMDIALYSIS BLOOD TUBING; TWISTER SET EXTRACOROREAL LINE

Lot Number 15LR01045

Device Problem Air Leak (1008)

Patient Problem Cardiac Arrest (1762)

Event Date 03/07/2016

Event Type  Death  

Event Description

Pt on hemodialysis machine approx 3 hours into scheduled 3-1/2 hours treatment when she became unresponsive.Called 911, cpr performed, and aed applied.Paramedics arrived to clinic.Pt was transferred to hospital where she later expired.Air noted in the extracorporeal circuit lines.

• Brand Name: COMBI SET TRUE FLOW SERIES HEMDIALYSIS BLOOD TUBING
• Type of Device: TWISTER SET EXTRACOROREAL LINE
• Manufacturer (Section D): FRESENIUS MEDICAL NORTH AMERICA; waltham MA 02451
• MDR Report Key: 5519374
• MDR Text Key: 41024551
• Report Number: 5519374
• Device Sequence Number: 0
• Product Code: FJK
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Lot Number: 15LR01045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2016
• Distributor Facility Aware Date: 03/07/2016
• Event Location: Other
• Date Report to Manufacturer: 03/18/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 72