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

Model Number CARDIOHELP

Device Problem No Flow (2991)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  Death  

Event Description

Complaint number: (b)(4).During patient transport the error message "disposable error-stop" appeared.As a medical intervention the emergency drive was used to hand-crank the patient.After return the disposable back to its cardiohelp it works without problems.Approx.10 minutes later the error message "p int above warning limit" appeared six times.The device worked normal and the patient's vital signs are stable.

Event Description

Complaint id:(b)(4).Additional information received on (b)(6)2020: after the error occurred, the engineer has preliminary checked the device and it worked normally, so it has been in use until (b)(6)2020 because the patient expired, due to his medical condition.

Manufacturer Narrative

Additional information received on (b)(6)2020: after the error occurred, the engineer has preliminary checked the device and it worked normally, so it has been in use until 2020-07-23 because the patient expired, due to his medical condition.

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

No service reports are available, however as per the correspondence attached, following the alarm, a preliminary evaluation by a getinge engineer confirmed the device was working as expected.The log files were analyzed on 2020-07-02.As stated in the logs the error message "pump disposable error" could be confirmed, but there were no further error messages that indicates a malfunction of the cardiohelp.All received data was forwarded to the medical affairs team.As stated in the medical review (dated on 2020-09-24): "after thorough review of the events detailed by the customer, a conclusive finding for the pump stop cannot be determined.It is possible during transport the hls set advanced was malpositioned or improperly seated in the cardiohelp drive not permitting the console to acknowledge the presence of the hls set advanced disposable.This may be supported by the normal functioning behavior once the disposable was reinserted to the same console.Additionally, a photo from the service technician shows a ¿pump disposable error¿ resulting in a pump stop which may support the possibility of an improperly seated hls advanced disposable in the cardiohelp drive.Pint indicates the pressure status of the venous prechamber for the hls set advanced.In regard to the ¿pint above warning limit¿ alarms which occurred repeatedly over a short period of time.A rising pint, with an unchanging part, may signal the presence of clot in the venous prechamber of the hls advanced set.This may manifest as a rising delta p.A pint alarm may also be the result of a faulty pint sensor, incorrect measurement of the venous prechamber, or an incorrectly set pint pressure limit (i.E.A warning, or an alarm if the pint intervention has been activated).The likelihood that the hls set advanced may not have been properly seated in the initial cardiohelp system, causing the behavior experienced by the user, may be assumed by the following: the hls disposable did not have evidence of obstruction on the arterial side of the circuit.(as reported to the getinge representative).The hls set advanced appeared to perform well after being moved to a different cardiohelp system/platform." thus the reported failure could be confirmed, but it was no product related malfunction.In addition no relation between the error and the death could be confirmed.The most probable root cause is an improper seated hls set.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.

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10259514
• MDR Text Key: 200038125
• Report Number: 8010762-2020-00222
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention