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 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was onsite for an investigation of the device.The fst adjusted the belt tension, tacho rpm and offset.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Further investigation is ongoing.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: "head".The error message: "head" can result in an unintentional pump stop.The instant of time is unknown.No harm to any person was reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in germany.On (b)(6) 2023, it was reported that the hl 20 pump displayed the error message "error head".No harm to any person has been reported.The event occured prior to use.A getinge field service technician (fst) was onsite for an investigation of the device on 2023-10-31.The fst could not reproduce the error message "error head".During investigation the fst confirmed the error message "beltslip", which means an indication to the user that the pump speed is smaller than 90% of the motor speed.The fst adjusted the belt tension and calibrated the tacho board.Safety, calibration, and functionality checks were performed to factory's specifications.All function tests are passed.No parts were replaced.According to the instructions for use of the hl 20 version 02 in chapter 8.1.2 technical alarms the error message: "beltslip" does not lead to a pump stop.The failure "beltslip" could be linked to the following most probable root cause according to the hl 20 risk management file: defective tacho, relay or pump belt.The reported failure "error head" could not be replicated, therefore not investigated.However the failure could be linked to the following most probable root cause according to the hl 20 risk management file: failure of pump control board.Defective/ dirty tacho, relay or pump belt.The review of the non-conformities during the period of 2020-12-07 to 2023-10-27 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 in question was manufactured on 2020-12-07.Based on the investigation results the reported failure "error head" could not be confirmed but the error message "beltslip" could be confirmed.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: 18099062
• MDR Text Key: 327697393
• Report Number: 8010762-2023-00555
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: 10/27/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1