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 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2023-01-30/24 and 2023-02-02.The no part was replaced.The flow/bubble sensor was cleaned by the fst.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the flow/bubble sensor displayed an error message, air was detected and caused a pump stop.The cardiohelp was exchanged during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the flow/bubble sensor displayed an error message, air was detected and caused a pump stop.The failure occurred during treatment.The cardiohelp was exchanged.A getinge field service technician (fst) was sent for investigation and repair on 2023-01-30/24 and 2023-02-02.The failure could not be reproduced.The affected flow/bubble sensor was cleaned by the fst, as there was dried blood on the sensor.There were no visible damages on the flow/bubble sensor or its cable.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The logfile analysis shows that on the date of event the error message "arterial bubble sensor defective" and "arterial bubble sensor disconnected" were displayed multiple times.The most probable root cause could be the dried blood which disturbed the reading of the flow/bubble sensor.However, according to the risk file of the cardiohelp device the following root causes can lead to the reported failure: bubble intervention not working/wrong information due to: - wrong bubble sensor information.- influence due to other ultrasonic devices.- bubble sensor disturbed.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 device was manufactured on 2021-10-01.The device history record (dhr) of the cardiohelp device was reviewed on 2023-02-08.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "flow bubble sensor defective" could be confirmed, but was not related to a device 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.

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: 16288614
• MDR Text Key: 308757623
• Report Number: 8010762-2023-00067
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/16/2023

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: 01/20/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1