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

Model Number HL 20

Device Problem Pumping Problem (3016)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "runaway".No harm to any person has been reported.A getinge field service technician will be sent onsite for investigation of the device.As soon as new information becomes available, a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 pump displayed the error message: "runaway" intermittently.No harm to any person was reported.Reference#: (b)(4).

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "runaway" during setup of the device.No patient was involved.A getinge field service technician was onsite and investigated the unit in question.The technician replaced the optical tacho board after that the pump did not display the error message.The hl20 device is back in use working to factory specification.The replaced optical tacho board was not available for further investigation at the manufacturer site.According to the service manual heart-lung machine hl 20 in chapter 6.11.6 adjustment of tpm optical tacho board the following is stated: the optical tacho must be adjusted after replacement or in case of speed differences between control system and safety system.Aging can change the properties of electronic components, which can cause it to have to be re-adjusted.However the failure mode "run away" error message can be linked to the following most possible root causes according to the hl 20 risk management file: -failure of pump control board defective/ dirty tacho, relay or pump belt.Thus the reported failure could be confirmed.The device was manufactured in 2018-07-06.The review of the non-conformities during the period of 2018-07-06 to 2022-09-05 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 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: 15359174
• MDR Text Key: 305686239
• Report Number: 8010762-2022-00357
• 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,Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 70103.3557
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose