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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); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2023
Event Type  malfunction  
Manufacturer Narrative
A getinge field service technician (fst) was sent for investigation and repair on 2023-01-19.The sensor panel was replaced and the cardiohelp software updated.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the logfile analysis the error message "venous bubble sensor defective" was displayed multiple times on the event date (b)(6) 2023.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that the error message ¿venous bubble sensor defective¿ was displayed.The failure occurred during treatment.No harm to any person has been reported.(b)(4).
 
Manufacturer Narrative
A getinge field service technician (fst) was sent for investigation and repair on 2023-01-19.The sensor panel was replaced and the cardiohelp software updated.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the logfile analysis the error message "venous bubble sensor defective" was displayed multiple times on the event date 2023-01-18.The affected sensor panel was investigated by getinge life-cycle-engineering on 2023-05-15 with following outcome: "based on the log files, it can be confirmed that there was an error with the venous bubble sensor.However, the problem itself cannot be reproduced with the supplied sensor panel.It is recommended to send in the venous bubble sensor as well so that a joint investigation of the venous bubble sensor together with the sensor panel can be carried out.".The review of the non-conformities has been performed on 2023-01-31 for the period of 2018-02-01 to 2023-01-18.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 2018-02-01.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Complaint id# (b)(4).
 
Manufacturer Narrative
It was reported that the error message ¿venous bubble sensor defective¿ was displayed.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair on 2023-01-19.The sensor panel was replaced and the cardiohelp software updated.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the logfile analysis the error message "venous bubble sensor defective" was displayed multiple times on the event date 2023-01-18.The affected sensor panel was investigated by getinge life-cycle-engineering on 2023-05-15 with following outcome: "based on the log files, it can be confirmed that there was an error with the venous bubble sensor.However, the problem itself cannot be reproduced with the supplied sensor panel.It is recommended to send in the venous bubble sensor as well so that a joint investigation of the venous bubble sensor together with the sensor panel can be carried out." the venous bubble sensor was requested for additional investigation and the customer received a new one.A further investigation was done by getinge life-cycle-engineering on 2023-08-30.The affected venous bubble sensor was investigated.The failure "venous bubble sensor defective" could be confirmed.However, a probable root cause is an user error.The sensor panel and venous bubble sensor are working accordingly, if the plugs are connected properly.The error "venous bubble sensor defective" occurs when the plugs are poorly connected.Removing the plug and connecting it again will reset the error, and the sensor can be used properly without a defective error message.According to the instructions for use, chapters 2.2.5 and 5.4.4 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 optional venous bubble sensor is for additional bubble detection.The review of the non-conformities has been performed on 2023-01-31 for the period of 2018-02-01 to 2023-01-18.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 2018-02-01.Based on the results the reported failure "venous bubble sensor defective" could be confirmed, but was not a device related malfunction.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-01-18 till 2023-01-18).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 Key16231997
MDR Text Key308161664
Report Number8010762-2023-00038
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K133598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/31/2023
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 Number701048012
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2023
Initial Date FDA Received01/24/2023
Supplement Dates Manufacturer Received05/15/2023
08/30/2023
Supplement Dates FDA Received05/19/2023
08/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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