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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CARDIOHELP-I
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2024
Event Type  malfunction  
Manufacturer Narrative
Two reported failures occurred during treatment.The first reported failure was that the venous bubble sensor would alarm ¿ven.Bubble sensor defective¿, when the cable was moved around.The second reported failure was that the venous probe was not accurately reading sv02 values.The venous probe failure is not reportable as a laboratory blood gas analysis must be performed.The venous bubble sensor failure is reportable.The venous bubble sensor was exchanged.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation on 2024-03-08.The fst could duplicate the venous bubble sensor error message by moving the venous bubble sensor cable around.Additionally, the fst confirmed that there as no visible damage on the venous bubble sensor or its cable.According to the fst, the venous probe sensor was the old style venous probe with 7 lenses.The venous probe sensor had no visible damage and was the original venous probe linked to the cardiohelp.The fst could not duplicate the venous probe sensor reading failure.The venous bubble sensor was replaced.The venous probe was replaced as a precautionary measure.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¿ and ¿ven.Bubble sensor disconnected¿ could be confirmed on the date of event, 2024-03-28.A similar venous bubble sensor with a similar failure was already investigated by the supplier.Following possible root causes were determined: damaged wiring inside the cable due to mechanical tension damage due to overvoltage or esd (electrostatic discharge) the exact root cause of the venous probe reading failure could not be determined due to the age of the venous probe, it was produced in 2015 and was the 7 lenses venous probe, age related aspects can be considered.A new generation of a venous probe was implemented in (b)(6) 2019.According to the instructions for use (ifu), chapters "monitoring and sensors" and "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor must 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 "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 "application overview for disposables", is stated that if the disposable was changed during operation the venous probe could be re-initialized again.To monitor the patient temperature the venous temperature is measured by the venous probe.Further in case of a failing arterial/venous temperature sensor an external sensor can be connected (refer to ifu , chapter "connecting external temperature sensors").According to the ifu of the cardiohelp chapter "messages", if the measured values are above high limit or below low limit of the set limits and if the sensor is defective the system generates a visual and acoustical alarm.The review of the non-conformities for the venous bubble sensor failure has been performed on (b)(6) 2024 for the period of (b)(6) 2015 to (b)(6) 2024.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 2015-10-16.Based on the results the reported failure "venous bubble sensor defective error when cable is move around¿ could be confirmed.Based on the results the reported failure ¿venous probe sensor reading" could not 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
Two reported failures occurred during treatment.The first reported failure was that the venous bubble sensor would alarm ¿ven.Bubble sensor defective¿, when the cable was moved around.The second reported failure was that the venous probe was not accurately reading sv02 values.The venous probe failure is not reportable as a laboratory blood gas analysis must be performed.The venous bubble sensor failure is reportable.The venous bubble sensor was exchanged.No harm to any person has been reported.Complaint id (b)(4).
 
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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 Key19069097
MDR Text Key339780994
Report Number8010762-2024-00192
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133598
Number of Events Reported1
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 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCARDIOHELP-I
Device Catalogue Number701048012
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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