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

Model Number CARDIOHELP-I

Device Problem Pumping Problem (3016)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the ecmo pump failed.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the ecmo pump failed.Subsequently, it was reported that the cardiohelp had an ac voltage failure.The error message, ¿ac voltage error¿ was displayed.The failure occurred during routine checks.Additionally, according to the logfiles, no pump failure occurred.As the failure occurred during routine check up and no pump failure occurred, this complaint is no longer reportable.A getinge field service technician (fst) was sent for investigation on (b)(4).No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and ¿ac voltage error¿ could be confirmed.The fst inspected the device and the logfiles and determined the root cause to be that the cardiohelp ac connection was disconnected and reconnected in a short amount of time, resulting in the ac voltage error.The cardiohelp system has a redundant power supply of an external power supply and battery supply.The redundant design of two usable batteries and the alarming about defect batteries cause a maximum safety.According to the instruction for use (chapter "check before every application", point 15) the user should only start the application when the batteries of the cardiohelp are fully charged and calibrated.An ac voltage error can occur if the device was disconnected/connected within 5 seconds.The review of the non-conformities has been performed on 2024-03-19 for the period of 2016-11-23 to 2024-02-27.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 2016-11-23.Based on the results the reported failure ¿ac voltage error¿ 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: CARDIOHELP
• 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: 18873206
• MDR Text Key: 337358106
• Report Number: 8010762-2024-00128
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133598
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1