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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the venous bubble sensor was alarming.It was later specified, that the device showed the error message "venous bubble sensor is defective".Cleaning the sensor elevated the problem for a short period of time, but it reoccurred.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair.The fst could replicate the failure by moving the cable of the sensor and eventually, the venous bubble sensor was replaced.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 the error message "venous bubble sensor is defective" could be confirmed on the date of event.No exact root cause could be determined.However, another venous bubble sensor with a similar failure was already investigated by the supplier sonotec.Following possible root causes were determined: damaged wiring inside the cable due to mechanical tension - damage due to overvoltage or esd (electrostatic discharge) according to the instructions for use (ifu), chapters 2.2.5 "monitoring and sensors" and 5.4.4 "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The venous bubble sensor is optional and for additional bubble detection.The review of the non-conformities has been performed on 2023-12-13 for the period of 2017-04-26 to 2023-12-04.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 2017-04-26.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter 5.3."connecting the sensors" in the instructions for use of the cardiohelp device.Based on the results the reported failure "error message: venous bubble sensor" 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

It was reported that the venous bubble sensor was alarming ¿venous bubble sensor is defective¿ when moving the cable.No harm to any person has been reported.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: 18325069
• MDR Text Key: 330486566
• Report Number: 8010762-2023-00619
• 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
• Report Date: 12/14/2023

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1