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

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2022

Event Type  Death  

Manufacturer Narrative

A getinge technician will investigate the cardio help.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that there was a pump stop due to a bubble alarm, which was triggered by the intervention of the flow bubble sensor.No harm to any person has been reported.Information received by the dcu on (b)(6) 2022 that patient expired: the event occurred in germany during treatment.A pump stop due to a bubble alarm of the was reported.Customer confirmed that the death was not in relation to the pump stop complaint id: (b)(4).

Manufacturer Narrative

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

Event Description

It was reported that there was a pump stop due to a bubble alarm, which was triggered by the intervention of the flow bubble sensor.Emergency drive was used.On 2022-08-31 information has been received that patient expired.Customer confirmed that the death was not related to the pump stop of the cardiohelp.Complaint id: (b)(4).

Manufacturer Narrative

On (b)(6) 2022, the patient was connected to the cardiohelp.On (b)(6) 2022 a blood sampling at the arterial outlet and subsequent flushing with saline solution was performed.After that, an air bubble alarm followed and the pump stopped.For approximately 10 minutes, there was no perfusion.After that, it was continued by hand with the emergency drive.The customer than replaced the affected cardiohelp with another unit for further automated perfusion.The customer stated that the expiration of the patient was unrelated to the cardiohelp.A getinge service technician (fst) was sent for investigation and repair on 2022-08-17.Based on the description of the event by the customer, the evaluation of the log files and the technical examination of the cardiohelp, a malfunction of the cardiohelp system could be excluded by the fst.The bubble monitoring worked as expected.Therefore no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the analyzed service log files, on (b)(6) 2022 at 04:23 o'clock there was a "arterial bubble detected" event with an active intervention.This was directly followed by a "pump stopped" event, as expected in such a case, where the intervention is set.A medical review was performed by getinge medical affairs on 2022-09-14 with the following conclusion: "based on the description of the event by the customer, the evaluation of the log files and the technical examination of the cardiohelp, a malfunction of the cardiohelp system may be excluded.The service report by the sales and service unit of getinge describes that the cardiohelp does not show a malfunction and that its functionality meets the factory requirements.The user describes an arterial bubble alarm and a subsequent pump stop.This pump stop is a selected behavior of the cardiohelp console when the corresponding intervention is switched on.This pump stop intervention prevents bubbles from being pumped into the patient.If a bubble alarm is active in combination with a switched-on intervention (automatic pump stop), the rpm (rotations per minute) cannot be increased (hence, flow is resumed) until the sensor is reset.After resetting the sensor on the user interface, perfusion is resumed at the previous rpm setting.It is assumed that during the process of resetting the bubble sensor the user confirms that bubbles are not present in the arterial limb of the circuit before actually resetting the arterial bubble sensor.One possible explanation for the ¿arterial bubble detected¿ alarm (with the associated pump stop) could be that a small bubble was inadvertently introduced to the extracorporeal system during flushing the sample line.The customer stated that the expiration of the patient was unrelated to the cardiohelp.The treatment was discontinued due to persistent global pump failure on the (b)(6) 2022.Based on the observations from the complaint narrative in addition to the statements from the customer, the expiration of the patient cannot be attributed to a diminution in performance or malfunction of the product (cardiohelp)." an exact root cause could not be determined for the reported failure, as no malfunction was identified with the cardiohelp, one possible root cause for the reported event is that a bubble was introduced during blood sampling.This action was performed by the user directly before the bubble alarm occurred, as confirmed by the customer.However, with reference to the current risk file, the following possible causes could also be linked to the reported failure: influence due to other ultrasonic devices (e.G.Flow sensor).Environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage).Sensors are disturbed by external electric or magnetic field (emi) or ultrasonic system.According to instructions for use, chapter 6.2.4 bubble monitoring this function monitors the occurrence of bubbles.For this purpose, the user can activate the intervention.If the intervention is set and when a bubble is detected on the arterial flow/bubble sensor, the cardiohelp-i generates a high-priority alarm and stops the pump.To restart the pump and end the alarm, the user must reset the bubble alarm.The review of the non-conformities has been performed on 2022-09-02 for the period of 2015-08-18 to 2022-08-17.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 2015-08-18.Based on the results the reported failure "arterial bubble detected and stopped the pump" no malfunction of the cardiohelp could 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: 15335278
• MDR Text Key: 299056308
• Report Number: 3008355164-2022-00026
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

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: 09/20/2022
• Distributor Facility Aware Date: 09/19/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/31/2022; 09/19/2022
• Supplement Dates FDA Received: 09/02/2022; 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death