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

Model Number CARDIOHELP-I

Device Problems Electrical /Electronic Property Problem (1198); Failure to Sense (1559)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the unit was alarming the error ¿defective venous bubble sensor¿ when placing on a patient.No harm to any person has been reported.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.

Event Description

Complaint id #(b)(4).

Manufacturer Narrative

It was reported that the unit was alarming the error ¿defective venous bubble sensor¿ when placing on patient.No visible damage or dirt was detected on the sensor,its cable or the sensor panel.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation on 2024-03-01 and 2024-03-05.The venous bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.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 2024-03-06 for the period of 2015-08-31 to 2024-03-06.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 2015-08-31.Based on the results the reported failure "venous bubble sensor defective error message" 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.

• 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: 18836112
• MDR Text Key: 336884991
• Report Number: 8010762-2024-00117
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1