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

Model Number CARDIOHELP-I

Device Problems Defective Alarm (1014); Communication or Transmission Problem (2896)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Following information about the event was provided: "dear support team, i found the following error in the cardiohelp.Event:(b)(4).Description: art.Bubble sensor defective.I checked the cardiohelp logs and found that i've had this error many times in the past.The first time this error occurred was last (b)(6).I attempted to inspect it on (b)(6) of this year and the error occurring again.Flow bubble sensor was not connected when this error occurred.I did a cross check of the machine and the flow bubble sensor.I connected some flow bubble sensors to this device and got the same error.When i looked at it again a few hours later, the error was no longer reproduced.No errors now as well.I believe the sensor panel is the cause, but i am having trouble reproducing the error anymore.Can you give me some advice on what to do?" complaint id# (b)(4).

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge technician will investigate the cardiohelp in question.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that there was an error message "arterial bubble sensor defective".This event was logged multiple times over an extended period of time.The failure occurred when the getinge service technician checked the cardiohelp logfiles.A getinge service technician (fst) was sent for investigation.He could reproduce the failure without a flow/bubble sensor connected.After doing a cross-check of the cardiohelp the failure is not reproducible anymore.The fst operated the cardiohelp for 10 days without an error message or any problems.The fst performed safety, calibration, and functionality checks to factory specifications.All tests passed.According to the logfile analysis the error message "arterial bubble sensor defective" logged on 2021-05-11 the first time and again on 2021-06-16, 2021-07-30, 2021-11-27, 2022-05-06.Before the error message occurred, the low prior message ¿flow sensor defective¿ occurred beforehand.An exact root cause could not be determined.However, with reference to the current risk file, the following possible causes could be linked to the reported failure: - influence due to other ultrasonic devices (e.G.Flow sensor) - connection of non-compatible sensor - environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage) - sensors are disturbed by external electric or magnetic field (emi) or ultrasonic system 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.Thus a defective flow/bubble sensor should be detected prior to use, during priming the review of the non-conformities has been performed on 2022-05-27 for the period of 2011-08-01 to 2022-05-06.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 2011-08-01.Based on the results the reported failure "error message: arterial bubble sensor defective" could be confirmed but not reproducible.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.Note: if new relevant information will become available the complaint will be reopened.

• 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: 14428478
• MDR Text Key: 300303242
• Report Number: 8010762-2022-00173
• 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: 06/20/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1