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

Model Number HL 20

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported that the engine did not run smoothly and made a noise.The event occurred during set up.No harm to any person was reported.During inspection also the error ¿head¿ was observed.(b)(4).

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

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the pump did not run smoothly and made a noise.The event occurred during set up.During inspection the error message ¿error head¿ was observed.No harm to any person was reported.A getinge field service technician (fst) was sent for investigation and repair on 2024-03-27.The belt was replaced, which solved the failure "motor made a noise".The motor was replaced, which solved the failure "error head".As a preventive measure also the optical tacho was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The most probable root cause for the failure "motor made a noise" is use related wear and tear of the belt, which is wearing parts und subject to annual replacement.According to hl20 service manual chapter 4.2 "replacement of belts on rpm" the belts which are found twisted, have wear, cracking, or service life over 12 months have to be replaced.A similar case for the failure "error head" was already investigated by the getinge life cycle engineering on 2022-09-09 with the following outcome.The rpm (roller pump module) motor consists of two main components, the motor itself (baumüller gdm100n2-396/0750) and a tachometer (baumüller ghts 406) connected to the motor drive unit.The tachometer generates a dc voltage signal that is proportional to the speed and is used to control the motor to the target speed set by the user.In the event of deviations between the target and actual speeds, the control system first attempts to adjust the speed of the motor to the target by regulating the motor.If this is not possible, the motor is stopped by the control system and the message "error head" will be displayed.The most probable root cause could be determined as a defective motor tacho produces a faulty speed signal.Even when the motor is not turning, the tacho produces a signal that corresponds with a high speed.The review of the non-conformities has been performed on 2024-04-17 for the period of 2015-12-10 to 2024-01-26.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 2015-12-10.Based on the results the reported failure "pump made noise and error message error head" 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: 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: 18901513
• MDR Text Key: 337619753
• Report Number: 8010762-2024-00138
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2024

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: 701027652
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1