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 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-12-19.The system control panel board, dual pressure module and the display board were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.(refer to service order report 44635270) the review of the non-conformities has been performed on 2023-12-29 for the period of 2020-12-07 to 2023-11-17.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 2020-12-07.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the hl 20 displayed the error message "em 07 err_5vtest" and intermittent the ¿no comm¿ error message.The instance of time was not reported.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl 20 displayed the error message "em 07 err_5vtest" and intermittent the ¿no comm¿ error message.The instance of time was not reported.No harm to any person has been reported.During service it was also identified that the dual pressure module was defect.A getinge field service technician (fst) was sent for investigation and repair on 2023-12-19.The master panel board, dual pressure module and the display board were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected master panel board, dual pressure module and the display board were not made available for further investigation at the manufacturer."eem 07 err_5vtest" and ¿no comm¿ failures: the reported failures em 07 err_5vtest" and ¿no comm¿ were assessed by the getinge life cycle engineering (lce) on 2024-01-23.The most probable root cause was determined as a defect capacitor on either of the two affected boards.This leads to a low 5v supply voltage and to the error message em07.If the voltage drops to such an extent that the master processor no longer works and the pumps lose connection the "no comm¿ error message is then displayed.The failure ¿em 07 err_5vtest¿ will always occur during self-test phase +5v-test.The pump performs a self-test when switched on.If an error is detected, the pump cannot be started and an error message is shown in the status display.Therefore this failure will be detected prior to use.The reported failure ¿no comm¿ can cause an unintentional pump stop.Therefore, a report is required due to the "no comm" error message."dual pressure module defect": a causal connection between the defect capacitor and the defect pressure module was assessed by the lce to be unlikely.However the failure "pressure module defect" can be linked to the following most possible root causes according to the hl 20 risk management file: (total) fail of system or system control because of: communication fails / disconnection (e.G.System control panel to console, console to pump)), sensor failure (e.G.Pressure sensors).According to the hl20 instructions for use hl 20 (chapter 5.7.1 switching on the hl 20, self-test and 5.7.4 pressure monitoring: function test) the pressure sensors and pressure channels will be checked on startup of the device during automated self test of the device and during function testing before use.Therefore, this failure will be detected prior to use.The review of the non-conformities has been performed on 2023-12-29 for the period of 2020-12-07 to 2023-11-17.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 2020-12-07.Based on the results the reported failure "error message "em 07 err_5vtest", ¿no comm¿ intermittently and dual pressure module defect." 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: 18424663
• MDR Text Key: 331896919
• Report Number: 8010762-2024-00006
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/28/2024

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: 12/19/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1