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

Model Number CARDIOHELP-I

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Arrhythmia (1721); Valvular Stenosis (2697); Asystole (4442)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that during support the patient was cardioverted several times.No alarms were sounded on the cardiohelp or cardiosave as a result of the cardioversions.The patient required a continuous renal replacement therapy (crrt) and the crrt device gave voltage error alarms.The crrt was replaced and rooms were changed, but the same failure occurred again.The crrt service technician told the customer that there is maybe a voltage leak from the cardiohelp or the cardiosave.The patient was not harmed according to the customer and is no longer on support.Complaint id# (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

The information was received that the patient had syncopal episodes at work.It was found that the patient have large pericardial effusion.Other diagnoses included were severe aortic stenosis and moderate mitral stenosis.The patient went into asystole arrest and was found down in the room.The cpr was initiated within 60 seconds.No cardiosave was used it was a cs300 according to the getinge service technician.A getinge field service technician (fst) was sent for investigation on 2023-10-16.No parts were replaced.The device was checked for a possible voltage leakage, but the electrical safety checks were all within specification.A complete preventive maintenance was performed and the device was returned to the customer.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).

Manufacturer Narrative

It was reported that during support the patient was cardioverted several times.No alarms were sounded on the cardiohelp or cardiosave as a result of the cardioversions.The patient required a continuous renal replacement therapy (crrt) and the crrt device gave voltage error alarms.The crrt was replaced and rooms were changed, but the same failure occurred again.The crrt service technician told the customer that there is maybe a voltage leak from the cardiohelp or the cardiosave.The patient was not harmed according to the customer and is no longer on support.Later the information was received that the patient had syncopal episodes at work.It was found that the patient have large pericardial effusion.Other diagnoses included were severe aortic stenosis and moderate mitral stenosis.The patient went into asystole arrest and was found down in the room.The cpr was initiated within 60 seconds.No cardiosave was used it was a third party device according to the getinge service technician.A getinge field service technician (fst) was sent for investigation on 2023-10-16.No parts were replaced.The device was checked for a possible voltage leakage, but the electrical safety checks were all within specification.A complete preventive maintenance was performed and the device was returned to the customer.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and no failure could be confirmed on the date of event a medical review was performed by getinge medical affairs on 2023-12-07 with following conclusion: "the complaint narrative describes a critically ill patient on veno-arterial and additional mechanical circulatory support, who required crrt, which could not be initiated alongside the cardiohelp and cardiosave device.This was due to high voltage alarms, whenever the crrt machine was plugged into a wall socket in the patient¿s room.On battery power, the machine worked, but was limited to three hours of runtime due to battery capacity.Any attempt to connect to the wall socket caused the machine to stop and display the ¿high-voltage¿ error.Per report the hospitals wall sockets were checked and showed regular voltage levels.Possible root causes for this situation could be an error current in the electronic infrastructure, but this was ruled out by the hospital¿s facility personnel.In addition, the crrt machine as well as the cardiohelp console have been checked for conformity and were found to be without error.In summary, given that all devices were tested to be within specified electronic parameters, it does not seem to be an individual device¿s fault, but the aberration of electric currents by simultaneous use of multiple devices in parallel on one circuit, which caused the alarm for the last device connected.The patient was not harmed, as determined by the customer, and is no longer on support." the review of the non-conformities has been performed on 2023-10-17 for the period of 2014-09-30 to 2023-10-12.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 2014-09-30.Based on the results the reported failure "leakage volt on cardiohelp" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-10-12 and 2023-10-12).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: 17949402
• MDR Text Key: 325839183
• Report Number: 8010762-2023-00504
• 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,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention