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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It war reported that the flow bubble sensor on the cardiohelp detects bubbles and cannot be reset.It was confirmed that the bubble intervention was turned off so the pump did not stop and no health problem to the patient occurred.Complaintnumber: (b)(4).

Manufacturer Narrative

A follow up will submitted when additional information become available.

Manufacturer Narrative

It war reported that the flow bubble sensor on the cardiohelp detects bubbles and cannot be reset.The hospital staff was able to reset the bubble sensor as they tried different mounting positions and other minor things.It was confirmed that the bubble intervention was turned off so the pump did not stop and no health problem to the patient occurred.The failure occurred during treatment.As confirmed by the getinge service and sales unit no service was performed by a getinge service technician.The customer only allowed the logs to be downloaded on site and does not allow to check and repair the cardiohelp.The customer confirmed, that the cardiohelp is in use and no re-occurance of the failure was reported (refer to comunication grid).The service and sales unit corrected the date of event to 2022-08-31.The service logs shows the mentioned error message "arterial bubble detected" multiple times on the date of event, but not a malfunction of the cardiohelp.The user logs shows "user has resetted bubble1 alarm".According to the instruction for use (ifu, chapter: "9 messages") of the cardiohelp the the "arterial bubble detected" alarm will occure, when gas bubbles in the system, or combined flow/bubble sensor removed from tubing.As the intervention was not activated, the pump did not stopped.Morover, within the instruction for use (ifu, chapter: "6.4.2 resetting the bubble stop") it is explained how to proceed in this case.Further, according to the instruction for use 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.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.According to the instructions for use (ifu) of the cardiohelp (chapter 10 cleaning and disinfection) the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in chapter 5.3 connecting the sensors it is stated that the sensors must be kept clean.The technician indicated that the error was probably caused by a user error by customer.However, according to the risk file v24 of the cardiohelp the following root causes can also lead to the reported failure: bubble sensor disturbed, bubble sensor not plugged but recognized, connection of non-capatible sensor, environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage, detection of no-existing bubbles.The review of the non-conformities has been performed on 2022-09-08 for the period of 2020-04-09 to 2022-09-01.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 to have contributed to the reported failure based on the results the reported failure "flow bubble sensor on the cardiohelp detects bubbles and cannot be reset" could not be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.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.Note: the failing venous probe will be investigated within another complaint.

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: 15359544
• MDR Text Key: 302938007
• Report Number: 8010762-2022-00358
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/04/2022

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: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose