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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2023

Event Type  malfunction  

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 after starting up, the flow/bubble sensor was defective.The following error messages appeared: ¿defective flow/bubble sensor¿ and ¿no flow/bubble sensor defective¿.The cardiohelp in question was not used and was exchanged.The failure occurred during set up.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the flow/bubble sensor was defective.The following error messages appeared: ¿defective flow/bubble sensor¿ and ¿no flow/bubble sensor detected¿.The cardiohelp in question was not used and was exchanged.The failure occurred during set up.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-07, 2023-08-10 and 2023-08-28.The sensor panel 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 "arterial bubble sensor defective" could be confirmed on the date of event, 2023-08-18.The same failure was already investigated by getinge life cycle engineering (lce) germany.An unreliable plug connection on the digiflow mini-board led to the error.However, according to the risk analyses v24 of the cardiohelp device the most probable root cause is a defective connection between the sensorbridge board and the digiflow board caused by an electro static discharge (esd).Therefore the error message "flow sensor defective" will be displayed.Referring 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 must 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 device was manufactured on 2022-01-18.The device history record (dhr) of the cardiohelp was reviewed on 2023-08-07.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "defective 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

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: 17379442
• MDR Text Key: 319926423
• Report Number: 8010762-2023-00352
• 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
• Report Date: 08/31/2023

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1