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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2023
Event Type  malfunction  
Event Description
It was reported that a ¿pump stop error¿ or possible other error that stopped the pump.The information from the customer was limited as he could not determine the specific alarm or cause of the error.The hls set was switched to the emergency drive and to another cardiohelp device.Than the hls set was switched back to the original cardiohelp console and functioned normally.Patient is currently on the original console.The failure occurred during patient treatment.No harm to any person was reported.Complaint id# (b)(4).
 
Manufacturer Narrative
It was reported that a ¿pump stop error¿ or possible other error that stopped the pump.The information from the customer was limited as he could not determine the specific alarm or cause of the error.The hls set was switched to the emergency drive and to another cardiohelp device.Than the hls set was switched back to the original cardiohelp console and functioned normally.Patient is currently on the original console.The failure occurred during patient treatment.A getinge field service technician (fst) was sent for investigation 2023-11-21.The fst was unable to reproduce the reported issue and ran the unit on the test set for 30 minutes without any issues.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 according to the fst there were no errors found in the logs.The "pump stop" event was logged, but the pump started at the same time again.Therefore the event "pump stop" could be confirmed on the date of event, but no failure of the device could be confirmed.As the failure was not reproducible and no error message was logged, the root cause remains unknown.According to the instruction for use (ifu) of the cardiohelp chapter 2.2.5 "monitoring and sensors" it is stated that the bubble sensor can trigger an unexpected pump stop in the following circumstances: during administration of contrast agents for diagnostics due to a difference in the acoustic properties of the fluids.During contrast echocardiography with microbubbles.Based on the results the reported event "pump stopped" could be confirmed, but was not related to a device malfunction.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.
 
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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 Key18197657
MDR Text Key328896719
Report Number8010762-2023-00583
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 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 NumberCARDIOHELP-I
Device Catalogue Number701072780
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2023
Initial Date FDA Received11/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2018
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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