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

Model Number CARDIOHELP-I

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that the error message ¿flow/bubble sensor defective¿ occurred.The pump did not stop but the flow reading went to dashes as the sensor was not functioning.The bubble alarm sounded and the cardiohelp was placed in the global override mode to silence the alarm.Another flow bubble sensor was used and the bubble alarm was cleared.The flow was displayed again.According to the customer the patient was not off support due to the sensor.The failure occurred during patient treatment.No harm to any person has been reported.Complaint id#(b)(4).

Manufacturer Narrative

It was reported that the error message ¿flow/bubble sensor defective¿ occurred.The pump did not stop but the flow reading went to dashes as the sensor was not functioning.The bubble alarm sounded and the cardiohelp was placed in the global override mode to silence the alarm.Another flow bubble sensor was used and the bubble alarm was cleared.The flow was displayed again.According to the customer the patient was not off support due to the sensor.The failure occurred during patient treatment.A getinge field service technician (fst) was sent for investigation and repair on 2023-11-16.The error was not reproducible, but the flow/bubble sensor was replaced as a precaution.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 by the fst and the error message "flow/bubble sensor defective" could be confirmed on the date of event.As the failure was not reproducible, no exact root cause could be determined.However, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: wrong bubble sensor information.Influence due to other ultrasonic devices.Bubble sensor disturbed.Environmental influences.Sensors are disturbed by external electric or magnetic field (emi).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.Moreover, according to the 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 review of the non-conformities has been performed on 2023-11-20 for the period of 2020-06-30 to 2023-11-17.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 2020-06-30.Based on the results the reported failure "flow/bubble sensor defective error message" could be confirmed due to the logfiles, but was 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.

• 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: 18198141
• MDR Text Key: 328907121
• Report Number: 8010762-2023-00584
• 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
• Report Date: 11/23/2023

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1