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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 Problems Electrical /Electronic Property Problem (1198); Decrease in Pressure (1490); Failure to Pump (1502); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2023
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 pump would not run or prime the test circuit when the rpm was turned up.Additionally, the sensor calibration via the service tool failed multiple times.At last, the customer stated that the venous pressure went from positive values to negative values when increasing the rpm.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that the pump would not run or prime the test circuit when the rpm was turned up.Additionally, the sensor calibration via the service tool failed multiple times.At last, the customer stated that the venous pressure went from positive values to negative values when increasing the rpm.The failures occurred during testing.A getinge field service technician (fst) was sent for investigation and repair on 2023-04-20.After filling the test circuit air free, the failures were resolved.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the fst following root causes led to the failure and were user errors: the priming failure occurred as the test circuit was not free of air.Therefore the priming procedure does not function correctly.The reading failure of the pressure and temperature was due to a handling failure of the service tool simulator.As stated in the service manual (cardiohelp system, service requirements) only authorized service technicians are allowed to carry out service-related work.Thus the issue regarding the service tool simulator can only occur during service of an authorized service technician.Further according to chapter 3.1 general information the device has to be checked after every maintenance or repair.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.2 priming the system and chapter 6.4 starting perfusion) the system has to be de-aired and free of gas bubbles.The review of the non-conformities has been performed on 2023-04-26 for the period of 2017-06-02 to 2023-03-07.It does not show any non-conformity in regard to the reported product and failures.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2017-06-02.Based on the results the reported failure "pump not running when turning up rpm" and "venous pressure reading wrong values" could be confirmed, but are not related to a malfunction of the device.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 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 Key16528754
MDR Text Key311484578
Report Number8010762-2023-00134
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,Followup
Report Date 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2023
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 Received04/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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