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 02/23/2024

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 error message ¿art.Bubble sensor defective¿ was continuously alarming and that the maintenance could not be completed due to the alarm.The technician attempted to install a new arterial bubble sensor but it did not correct the issue.The failure occurred during maintenance.No harm to any person has been reported.Complaint id # (b)(4).

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation on 2024-03-31.The arterial bubble sensor was replaced, which did not resolve the issue, the fst sent the cardiohelp for repair in the depot.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the error message ¿art.Bubble sensor defective¿ was continuously alarming and that the maintenance could not be completed due to the alarm.The technician attempted to install a new arterial bubble sensor but it did not correct the issue.The failure occurred during maintenance.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation on 2024-03-31.The arterial bubble sensor was replaced, and the cardiohelp was sent for repair in the getinge depot.The getinge depot confirmed that there was no damage or contamination to the sensor panel.The sensor panel was 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 ¿art.Bubble sensor defective¿ could be confirmed on the date of event.According to the getinge life cycle engineering (lce) germany, the most probable root cause was a disconnection between the sensor panel and digiflow mini-board.A similar failure was investigated by the lce.An unreliable plug connection on the digiflow mini-board led to the error.Moreover, according to the risk analyses v24 of the cardiohelp device the most probable root cause is a defective connection between the sensorbridge board and the digiflow board caused by an electro static discharge (esd).According 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.The device was manufactured on 2022-04-26.The device history record (dhr) of the cardiohelp was reviewed on 2024-04-26.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 "art.Bubble sensor defective, continuously alarming" 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 #(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: 18806518
• MDR Text Key: 336545681
• Report Number: 8010762-2024-00110
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1