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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HL 20
Device Problems Pumping Stopped (1503); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
Event Type  malfunction  
Event Description
It was reported that during treatment the sensor control panel turned off and the arterial pump stopped.After restarting the hl20, the panel turns on and works normally.This shutdown of the sensor control panel occurred several times.No harm to any person has been reported.Complaint id:(b)(4).
 
Manufacturer Narrative
The investigation is ongoing.A getinge technician will investigate the cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.
 
Manufacturer Narrative
It was reported that the sensor control panel turned off and the arterial pump stopped.After restarting the hl20, the panel turns on and works normally.This shutdown of the sensor control panel occurred several times.There were no error messages and the hand crank was not used.The failure occurred during treatment.No harm to any person has been reported.Due to the current sanctions on russia it is unclear when or if the repair can be completed.So far the device could not be inspected and it is unknown if or which components might be affected.Therefore the actual root cause could not be determined.However the reported failure could be linked to following most probable root cause according to the risk management file: operator can not see alarms, can´t override (bubble, level, pressure) intervention because of e.G.: display failure or master failure; system control panel (scp) monitor failure; communication fails / disconnection (e.G.Scp to console, console to pump)).Arterial pump doesn´t start, unintended stopped or slowed down because of e.G.: user error; component defective; communication error.The review of the non-conformities has been performed on 2023-05-25 for the period of 2020-12-07 to 2023-05-23.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 2020-12-07.Based on the results the reported failure "sensor control panel turned off and the arterial pump stopped" 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.If any new relevant information will be received the complaint will be reevaluated and if necessary reopened.H3 other text : unclear if device evaluation will be possible due to current sanctions on russia.
 
Event Description
It was reported that the sensor control panel turned off and the arterial pump stopped.After restarting the hl20, the panel turns on and works normally.This shutdown of the sensor control panel occurred several times.There were no error messages and the hand crank was not used.The failure occurred during treatment.No harm to any person has been reported.Complaint id: (b)(4).
 
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Brand Name
HEART LUNG MACHINE
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
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Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key17008960
MDR Text Key316007391
Report Number8010762-2023-00243
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K943803
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
Report Date 09/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number701028580
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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