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

Model Number CARDIOHELP-I

Device Problems Unable to Obtain Readings (1516); Communication or Transmission Problem (2896)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that the venous bubble sensor was defective and that the venous probe could not read svo2 values.The error message "ven.Bubble sensor defective¿ was displayed.The venous probe was initialized but could not read any values.The failure occurred during use.The failure ¿venous bubble sensor defective¿ is a reportable event as it is a high priority alarm which can lead to zero flow mode.The failure ¿venus probe not reading svo2 values¿ is not a reportable event, as these values must be regularly checked by the user via a blood gas analysis by a laboratory.A getinge field service technician (fst) was sent for investigation and repair on 2024-02-22.The fst confirmed that there was no visible damage to the venous bubble sensor and its cable.The venous bubble sensor and venous probe were 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 ¿ven.Bubble sensor defective¿ could be confirmed on the date of event, 2024-02-22.Another venous bubble sensor with a similar failure, ¿venous bubble sensor defective¿, was already investigated by the supplier (b)(4): following possible root causes were determined: damaged wiring inside the cable due to mechanical tension; damage due to overvoltage or esd (electrostatic discharge); according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure, ¿venus probe not reading svo2 values¿: wrong measurement values caused by sediments in the disposable; light influences; blood light spectrum differences; response time is too long; programming transmission error.According to the instructions for use (ifu), chapters 2.2.5 "monitoring and sensors" and 5.4.4 "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The venous bubble sensor is optional and for additional bubble detection.The venous probe does not influence the blood flow of the device.The venous probe is for monitoring the blood gas values (hemoglobin (hb), hematocrit (hct), oxygen saturation (svo2) and venous temperature).In the ifu, chapter 2.2.5 "monitoring and sensors" of the cardiohelp system it is stated that these values must be regularly checked by the user via a blood gas analysis by a laboratory.Furthermore, in the ifu is stated that prior to a therapeutic measure based on the parameters displayed, a laboratory blood gas analysis must be checked.The cardiohelp generates an acoustic and visible alarm in case of a failure of the venous probe.Additionally, in the ifu, chapter 5.1 "application overview for disposables", is stated that if the disposable was changed during operation the venous probe could be re-initialized again.The review of the non-conformities has been performed on 2024-02-27 for the period of 2016-06-03 to 2016-06-03.It does not show any non-conformity in regard to the reported product and failures, ¿venous bubble sensor defective¿ and ¿venus probe not reading svo2 values¿.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2016-06-03.Based on the results the reported failures ¿venous bubble sensor defective¿ and ¿venus probe not reading svo2 values¿ 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

It was reported that the venous bubble sensor was defective and that the venous probe could not read svo2 values.The error message "ven.Bubble sensor defective¿ was displayed.The venous probe was initialized but could not read any values.The failure occurred during use.The failure ¿venous bubble sensor defective¿ is a reportable event as it is a high priority alarm which can lead to zero flow mode.The failure ¿venus probe not reading svo2 values¿ is not a reportable event, as these values must be regularly checked by the user via a blood gas analysis by a laboratory.No harm to any person has been reported.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: 18806513
• MDR Text Key: 336545645
• Report Number: 8010762-2024-00111
• 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: 02/29/2024

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1