MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH PERFUSION TUBING SYSTEMS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 44063700

Device Problems Disconnection (1171); Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Per perfusionist's account.This case was a scheduled case.We had just finished the procedure, the cross clamp was off, and rewarming was almost complete.Our bladder temp was 35.8.With a goal of 36.5.The arterial line pressure was 215mmhg, our max.Arterial line pressure is maintained <300mmhg.I was flowing at 3.98 lpm, rpm 2555, arterial line pressure was 215mmhg, bladder temp was 35.8, do2 286.These parameters were maintained throughout the case.At this point, the tubing coming from the venous reservoir into the biohead connecting to the inlet hub of the oxygenator, disconnected.The team clamped both the arterial line and the venous line.Anesthesia positioned the patient in deep trendelenburg.Because of the amount of blood being pumped onto the floor, initially it was difficult to determine where the disconnection occurred.When i located the tube i clamped my arterial line proximal to my arterial line filter and reconnected the tubing to the oxygenator inlet hub.The drive line (venous reservoir into the biohead connecting to the inlet hub to the oxygenator) and the oxygenator did not deprime, so i started to recirculate the blood from the oxygenator into the venous reservoir to make sure no air was in the oxygenator.The blood loss that ended up on the floor was approximately 2l.This was the volume in my venous reservoir.No additional patient volume was lost during this incident.The next step was to clamp the arterial line distal to the arterial line filter, remove the clamp that was proximal to the arterial line filter and recirculate blood through the filter, the manifold, and into the venous reservoir to make sure no air was anywhere in my arterial line.The team at the field noticed some air was located in the arterial cannula.This air was sucked in by the root vent through the purse strings and into the cannula.The vent was turned off, the arterial line was briefly disconnected, and the cannula was refilled by the surgeon.The arterial line was reconnected to the arterial cannula, the line and cannula were inspected for air, and once we were satisfied with the integrity of the arterial line.Bypass was restarted.The whole process described above took approximately 2 minutes.The hct was low due to blood loss and 4 units of pack red cells (prcs) and 2 units of fresh frozen plasma (ffp) were given on bypass.We came off pump with good hemodynamic function and the patient was transferred to the cardiovascular intensive care unit (cvicu).Also of note: patient was extubated evening of surgery and neuro status was stable at discharge.

• Brand Name: PERFUSION TUBING SYSTEMS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 15378438
• MDR Text Key: 299474728
• Report Number: 15378438
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 44063700
• Device Lot Number: 2205400015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male
• Patient Weight: 160 KG