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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); Pumping Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Manufacturer Narrative
It was reported that the hl20 roller pump module displayed the error message: "safety-s".This error message can lead to an unintentional pump stop.The instant of time is unknown.No harm to any person has been reported.A getinge field service technician will be sent onsite for an investigation of the device.As soon as new information becomes available a follow up medwatch will be submitted.
 
Event Description
It was reported that the hl20 roller pump module displayed the error message: "safety-s".This error message can lead to an unintentional pump stop.The instant of time is unknown.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that the hl20 displayed the error message: "safety-s" during routine check.No harm to any person has been reported.A getinge field service technician (fst) was onsite for investigation and repair.The fst replaced the motor.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A defective motor was already investigated in the getinge life cycle engineering on 2022-09-09 with the following results: the rpm (roller pump module) motor consists of two main components, the motor itself (baumüller gdm100n2-396/0750) and a tachometer (baumüller ghts 406) connected to the motor drive unit.The tachometer generates a dc voltage signal that is proportional to the speed and is used to control the motor to the target speed set by the user.In the event of deviations between the target and actual speeds, the control system first attempts to adjust the speed of the motor to the target by regulating the motor.If this is not possible, the motor is stopped by the control system and the message "error head" will be displayed.In addition to the control system, the speed and the specification are monitored by the safety system.This is intended to react if the control system does not detect a deviation or does not react to it.In this case, the motor is also stopped and the message "error safety-s" will be displayed.A functional testing was also performed and the reported error message could be reproduced and a defective motor tacho was identified as the root cause.Even when the motor is not turning, the tacho produces a signal that corresponds with a high speed.The most probable root cause could be determined as a defective motor tacho produces a faulty speed signal.The device in question was manufactured on 2016-03-17.The review of the non-conformities during the period of 2016-03-17 to 2023-11-06 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.Based on the investigation results the reported failure "safety-s" could be confirmed.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
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
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key18100069
MDR Text Key327711462
Report Number8010762-2023-00559
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeIN
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 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
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 Received02/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2016
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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