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

Model Number HL 20

Device Problem Pumping Stopped (1503)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A getinge technician will investigate the hl 20.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that there was a "stop-- " error message on the art pump.And that there was an "err_04" error message displayed on the monitor.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that there was a "stop--" error message on the art pump.And that there was an "er 04 err_adconv" error message displayed on the monitor.The event occurred during a routine inspection.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023 (b)(6).The dpm 20-440 dual pressure module was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.No visual defects observed on pressure module or cable.The affected dual pressure module is not available for further investigation.Most probable root causes for the reported failure were assessed in an investigated by the getinge life cycle engineering on 2020 (b)(6) with the following outcome.1.Defects (cable break, bent or broken pins, etc.) on the sensor cable or sensor itself.2.Mechanical defect of the sensor socket on the dpm.3.Electrical defects within the dpm.An assessment of similar event related to the error message "er 04 err_adconv" was performed by getinge life cycle engineering on 2023 (b)(6) with the following outcome: it is plausible that the disconnection and reconnection of the motor controller board did solve the reported failure.During the self-test of the device the processor generates a voltage signal on the controller board.This signal runs back to the controller board via the motor controller board and is analyzed there in another channel of the processor.If there was a contact problem here (e.G.Due to corrosion of the contacts), it can be rectified by removing and reinserting the motor controller board.The most probable root cause is therefore a contamination of the contacts connecting the motor controller board through corrosion.The review of the non-conformities has been performed on 2023 (b)(6) for the period of 2018 (b)(6) to 2023 (b)(6).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 2018-05-15.Based on the results the reported failure "stop-- and er 04 err_adconv" 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.

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-11-14.The dpm 20-440 dual pressure module was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2023-11-27 for the period of 2018-05-15 to 2023-09-08.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 2018-05-15.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that there was a "stop--" error message on the art pump.And that there was an "er 04 err_adconv" error message displayed on the monitor.The event occurred during a routine inspection no harm to any person has been reported.Complaint id: (b)(4).

• 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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17743485
• MDR Text Key: 323365569
• Report Number: 8010762-2023-00461
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

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: HL 20
• Device Catalogue Number: 701043262
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 11/20/2023; 12/06/2023
• Supplement Dates FDA Received: 12/06/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1