MAUDE Adverse Event Report: LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 044063700

Device Problem Disconnection (1171)

Patient Problems Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Livanova has received a report that, during a bypass procedure, the arterial line tubing disconnected from the outlet of the reservoir.The perfusionist reconnected and tie banded it.This is a connection the perfusionist makes.Approximately 2 liters of patient blood was lost.There is no report of any patient injury.

Manufacturer Narrative

Device available for evaluation: the device is available.Sorin group italia manufactures the smart perfusion pack.The incident occurred in annapolis, maryland, united states of america.The complained part is available during follow up with the customer, livanova clarified the following information: the patient is fine and has been discharged from the hospital.Patient was not administered of blood bank following the event.Reservoir from with the tubing disconnected is a livanova¿s reservoir.The connection that disconnected was not tie banded before disconnection.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

On 8 september 2022, livanova has received the fda medwatch (b)(4).The report is relevant to a livanova case for which the report id: 1718850-2022-00050 was submitted on 01 september 2022.Below the information received through the medwatch (b)(4): "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." according to the above information, bank blood was administered to the patient on bypass while in the initial information livanova received, it was indicated that no bank blood was administered to the patient.Due to this new information, the case has been reassessed as serious injury and the present report is being submitted.

Event Description

See intial report.

Manufacturer Narrative

Livanova has received a report that, during a bypass procedure, the arterial line tubing disconnected from the outlet of the reservoir.The perfusionist reconnected and tie banded it.This is a connection performed by perfusionist.Approximately 2 liters of patient blood was lost.There is no report of any patient injury.During follow up with the customer, livanova clarified the following information: -the patient is fine and has been discharged from the hospital.Bank blood was administered to the patient on bypass while in the initial information livanova received, it was indicated that no bank blood was administered to the patient.The reservoir from which the tubing disconnected is a livanova¿s reservoir.The connection that disconnected was not tie banded before disconnection.The disconnection occurred at the oxyegantor inlet point; the analysis of the complaints database did not reveal further similar issues reported for this pts lot.Moreover, a review of the dhr could not identify any deviations or nonconformities relevant to the issue.Two lines (connected to oxygenator inlet) of the involved pack were received in livanova usa for investigation.Tubing dimensional analysis of the wall thickness and cpk were confirmed to be within specification.Dimensional analysis the inner diameter could not be measured due to how the sample was shipped back to livanova based on the above, livanova ruled out a manufacturing deficiency.Considering that the connection was not made by livanova and was not tie bended by the customer when the issue occurred, it is reasonable to assume that the disconnection was caused by: - an overpressure condition at the disconnection point.- tubing not fulling pushed into the oxygenator inlet barb by the medical team.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market for similar events.

Event Description

See intial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15336024
• MDR Text Key: 305600598
• Report Number: 1718850-2022-00050
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622147050
• UDI-Public: (01)00803622147050(240)044063700(17)240229(10)2205400015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 044063700
• Device Lot Number: 2205400015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1