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 08/11/2023

Event Type  malfunction  

Event Description

It was reported that the hl 20 twin pump showing "error head" and two single pumps showing "ad-conv." the failure occurred during a routine check.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2023.For the single pumps two motor control boards were replaced.For the twin pump the optical tacho board 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 (b)(6) 2023, for the period of (b)(6) 2018 to (b)(6) 2023.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.

Manufacturer Narrative

It was reported that the hl 20 twin pump showing "error head" and two single pumps showing "ad-conv".The failure occurred during a routine check.The failure "ad-conv" is related to the self-test of the hl 20, which is performed prior to use.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-17.For the single pumps two motor control boards were replaced.For the twin pump the optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.No exact root cause could be determined for the failure "error head, because the defective parts were not available for further investigation.However the failure was already investigated in a similar complaint by the getinge life cycle engineering on 2019-08-26 with the following outcome.The most probable root cause could be determined as a broken wiring of the optical tacho board.Further for the reported error message the following most probable root cause according to the risk management file could be determined: (total) fail of device because of: - defective tacho.No exact root cause could be determined for the failure "ad-conv", because the defective parts were not available for further investigation.However the failure was assessed by the getinge life cycle engineering on 2023-09-14.The ad-conv error is caused by a failed adc test.This test is carried out in the control board by the microcontroller, where a signal generated in the motor control board is tested.Therefore the most probable root cause was determined as a defective component in the motor control board.The review of the non-conformities has been performed on 2023-08-28 for the period of 2018-05-15 to 2023-08-11.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 "twin pump showing "error head" and two single pump showing "ad-conv"" 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: 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: 17630411
• MDR Text Key: 322034189
• Report Number: 8010762-2023-00429
• 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
• Report Date: 10/06/2023

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: 08/11/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1