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

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

According to the instruction for use of the cardiohelp device (chapter "save hospital configurations") it is the responsibility of the key user to verify the default setting of the hospital are set for every cardiohelp before use.Those configurations are used automatically when the cardiohelp is switched on.Referring to the instruction for use (chapter ¿system modes¿) the user should only use the cardiohelp-i with activated arterial bubble monitoring which triggers an intervention and/or an alarm when bubbles are detected.In addition (chapter ¿monitoring and sensors¿) the user has to test the arterial bubble monitoring before each use.Moreover in chapter ¿check before every application¿ it is stated to check every intervention selected by simulating an alarm condition.After a system restore the settings before are not saved and has to be again set by the user.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 pump stopped in response to a bubble alarm.The failure occurred during treatment.The patient nearly arrested after a few seconds due to the pump stop.The cardiohelp was in vv ecmo mode and no bubble was detected on inspection of the return line.This failure occurred because the bubble-interlink alarm intervention on the cardiohelp device was activated.The cardiohelp was before use serviced.No harm to any person has been reported.Complaint id (b)(4).

Event Description

Complaint (b)(4).

Manufacturer Narrative

It was reported that the pump stopped in response to a bubble alarm.The patient nearly arrested after a few seconds due to the pump stop.The cardiohelp was in vv ecmo mode and no bubble was detected on inspection of the return line.This failure occurred because the bubble-interlink alarm intervention on the cardiohelp device was activated.The cardiohelp was before use serviced.On 2024-01-19 the information was received that the customer requested to have the intervention on his devices permanently to be disabled.A getinge field service technician (fst) was sent for investigation and repair on 2024-01-19.No part was replaced as the cardiohelp functioned as intended.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.(refer to service order (b)(4)).The log files of the reported cardiohelp device were reviewed and the pump stop due to the bubble intervention being on could be confirmed on the date of event.There was no failure of the device.Therefore, according of the product manager of the cardiohelp device.It is the decision of the customer, if the intervention of the cardiohelp device will be used or not.As written in the cardiohelp instruction for use (chapter 6 during application) to only operate the cardiohelp with activated pressure and temperature sensors and to ensure that the warning and alarm limits, as well as interventions, are suitable for the patient and current situation.Referring to the instruction for use (ifu) chapter 5.3.1 "connecting the combined flow/bubble sensor" the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the ifu chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.Based on the results the reported event "pump stop due to activated intervention" could be confirmed, but is no product malfunction.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: 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: 18342847
• MDR Text Key: 330781436
• Report Number: 8010762-2023-00631
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1