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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2023

Event Type  Death  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the cardiohelp shut down due to a venous and arterial air bubble.The failure occurred during treatment.The cardiohelp was paused till the alarm was corrected.The circuit was exchanged but the patient expired.As stated by the customer the patient did not expired due to the cardiohelp device.There was no visible damage on the flow/bubble sensor.Complaint id (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp shut down due to a venous and arterial air bubble.The event occurred during treatment.The cardiohelp was paused till the alarm was corrected.The circuit was exchanged but the patient expired.As stated by the customer the patient did not expired due to the cardiohelp device.The hls set was discarded by the customer.The perfusionist confirmed that there was no fault either on the cardiohelp device nor on the hls set.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-23 and 2023-09-06/15.There was no visible damage on the flow/bubble sensor.The unit was tested for two weeks.There was no failures at this time and the reported event could not be replicated.The unit was operating like it should.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A medical review was performed by getinge medical affairs on 2023-09-27 with following conclusion: "the service and user pool logfiles pulled from the cardiohelp console suggest that the console responded as expected.According to the pool data, at 16:25:21 (05 aug 23) a bubble was detected by the cardiohelp bubble-sensor which resulted in the pump stop.In response to the pump stop, the user unlocked the user interface then activated global override.The arterial bubble was reset roughly 3 minutes after global override was activated.After the arterial bubble sensor was reset, the global override was deactivated.On 06 aug 23 at 06:29:24, a second bubble was sensed by the arterial bubble sensor, which resulted in a pump stop.The user pool data indicates that global override was activated, which, again, resulted in restarting of the pump.Shortly thereafter (07:08:27), the cardiohelp console was switched (powered) off.It appears that the global override feature was activated during support to restart the pump, then the arterial bubble sensor was reset.As noted in the ifu, the activation of global override disables all available interventions, which, in this complaint, restarted the pump which was stopped by an active intervention.As a note, the complaint narrative does not mention a confirmation that the circuit was free of air/bubbles.That said, the user and service pools show that air was detected by the cardiohelp bubble sensor.The intervention of cardiohelp (i.E., to stop the pump in the presence of bubbles/air) is the designed response intended to prevent the inadvertent delivery of air to the patient.According to the data provided by the service and user pools of the cardiohelp console (serial no.(b)(6)), in addition to the report from the local getinge service technician of no diminution in performance, it appears that the cardiohelp console responded as expected and as designed.Further, no details regarding the patient (viz., presentation, comorbidities, constitution, etc.) were divulged; therefore, it is challenging to associate the expiration of the patient to either malperformance or diminution in performance of the product." according to the instruction for use (ifu) of the cardiohelp, chapter 2.2.5 "monitoring and sensors" the cardiohelp should only be used with activated arterial and optional venous bubble monitoring which triggers an intervention (pump stop) and/or alarm when bubbles are detected.Ensure that trained medical personnel are always present and able to respond to a bubble alarm immediately, to remove the cause and reset the bubble alarm.The review of the non-conformities has been performed on 2023-08-31 for the period of 2013-05-02 to 2023-08-22.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2013-05-02.Based on the results the reported event "venous and arterial air bubble in system" could be confirmed, but no failure of the device.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).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2023-08-23 and 2023-09-06/15.The unit was tested for a two weeks.There was no failures at this time and the reported failure could not be replicated.The unit was operating like it should.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

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: 17622829
• MDR Text Key: 321931751
• Report Number: 3008355164-2023-00037
• 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: Distributor
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Distributor Facility Aware Date: 09/27/2023
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 09/15/2023; 09/27/2023
• Supplement Dates FDA Received: 09/19/2023; 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death