MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CARDIOVASCULAR PROCEDURE KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 64725

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Device Dislodged or Dislocated (2923); Protective Measures Problem (3015)

Patient Problem Cardiac Arrest (1762)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

Patient on extracorporeal membrane oxygenation (ecmo).Perfusionist at bedside when alarm for low pressure sounded from ecmo machine.Perfusionist found blood on floor and noticed that pigtail had become dislodged at connection point to oxygenator.Patient arrested while new pigtail was primed.Ecmo flows returned and patient back to baseline.Assumption is that connection point loosened over time or through patient movement/torque.Neither device was cracked or broken.Spontaneous disconnect.

Event Description

Patient on extracorporeal membrane oxygenation (ecmo).Perfusionist at bedside when alarm for low pressure sounded from ecmo machine.Perfusionist found blood on floor and noticed that pigtail had become dislodged at connection point to oxygenator.Patient arrested while new pigtail was primed.Ecmo flows returned and patient back to baseline.Assumption is that connection point loosened over time or through patient movement/torque.Neither device was cracked or broken.Spontaneous disconnect.

• Brand Name: CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• MDR Report Key: 17974979
• MDR Text Key: 326148983
• Report Number: 17974979
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 64725
• Device Lot Number: 0000340444
• 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: 10/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Race: White