MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

The following was reported: ¿i have a patient that has fibrotic lungs and is on working to make the transplant list.Frequently when he coughs, and he does cough a lot, his bubble detector alarm goes off and support stops.¿ no more details were provided, but requested.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The following was reported: ¿i have a patient that has fibrotic lungs and is on working to make the transplant list.Frequently when he coughs, and he does cough a lot, his bubble detector alarm goes off and support stops.¿ the event occurred during treatment and no harm to any person has been reported.The event was analyzed by getinge medical experts and the following was confirmed by customer: the arterial sensor was switched out without an event, i.E.After the arterial sensor was switched out, there was not another instance of the cardiohelp stopping when the patient coughed.It was unclear to the attending clinicians why the pump stopped at the same time (simultaneously) of the coughing fits experienced by the patient, but its clear that the reported pump stops ceased after the arterial sensor was exchanged.It was confirmed by getinge medical experts that the customer has been contacted several times for further information.However, the customer cannot provide any further information and does not created a service call.No service was performed by getinge service technician, as the arterial sensor (flow/bubble sensor), was replaced by the customer.The sensor is not available for investigation.Thus, no exact root cause could be identified.However, in reviewing the details of the event, the following possible root causes were determined by getinge medical experts: the increased intrathoracic pressure caused retrograde flow through the circuit, changing the acoustic properties of the blood, thereby causing the arterial sensor to falsely trigger.The arterial sensor cabling was damaged and unnoticed by the attending clinicians.When the patient coughed, the tubing shook the arterial sensor causing the arterial sensor to falsely trigger.The arterial sensor was intact and fully functional, but the aggressive movement of the arterial sensor (on the tubing) during coughing fits triggered a pump stop during the conversation, the customer proposed that the coughing fit(s) may have caused a brief stoppage of blood flow through the circuit (i.E.Due to high applied intrathoracic pressure), allowing the sweep gas flow in the gas phase to be briefly higher than the flow in the blood phase until the flow started again, thereby allowing some microair (via cavitation, or migration across the membrane) which was sensed by the arterial bubble sensor, stopping the pump.However, the customer stated that no backflow protection alarm was triggered.The customer stated that no visible air was identified upon inspection of the arterial bubble sensor.The customer stated that the hls set was never higher than the level of the patient it is assumed that this scenario may be created due to a delta in pressure of the gas and blood phases respectively.It is assumed that gas flow, per se, may not apply.The gas flow (8-10 lpm) was well within the operating recommendations of the product ifu (> 14 lpm) because the venue of support was vv, it is assumed that a high intrathoracic pressure would have been applied equally both limbs of the vv circuit as both the entry and the exit of the circuit began and terminated close to/in the right atrium as seen in ij cannulation.An equal application of high pressure in both limbs of the circuit would have maintained a blood phase pressure higher than the gas phase pressure, likely preventing gas entrainment, migration, and/or cavitation.The customer stated that the yellow deairing cap was on the hls set during the event, preventing entrainment of air into the circuit at the time of the event through the deairing port, i.E.If negative pressure were applied to the circuit.An undetected septal defect, or communication with other iv lines proximal to the ij cannula, may have allowed aspiration of microair into the circuit which may have been registered by the arterial bubble sensor.It is assumed that this would not have been a simultaneous event as reported by the customer.High peep setting may have increased intrathoracic pressure which may have exacerbated the high intrathoracic pressure seen in the coughing fits.Further, this may have decreased venous return to the machine, causing possible cavitation which may have been registered by the arterial bubble sensor.It is assumed that this also would not have been a simultaneous event as reported by the customer.According to the instruction for use chapter 5.3.1 connecting the combined flow/bubble sensor the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.Based on the results the reported failure "frequently when patient coughs, and he does cough a lot, his bubble detector alarm goes off and support stops" could not be confirmed.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16182269
• MDR Text Key: 307881676
• Report Number: 8010762-2023-00022
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: N/I
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1