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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 Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
It was reported that single pump displayed the error message "beltslip" and ¿direct¿ and the twin pump the error message: "overload".The event occurred during a routine check.No harm to any person was reported.Complaint id: (b)(4).
 
Manufacturer Narrative
The investigation is ongoing.A getinge technician will investigate the hl 20.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that single pump displayed the error message "beltslip" and ¿direct¿ and the twin pump the error message: "overload".The event occurred during a routine check.No harm to any person was reported.Unit is not covered under any getinge maintenance contract.It was maintained by the hospital itself.During an inspection of the device by a getinge field service technician multiple components like monitor, pump head, tacho boards, sensors, belt, batteries and switches were identified as in need of replacement.However the customer is interested in replacement of equipment instead of repairing the 15 years old device.The defective components were not available for further investigation and the exact root cause for the multiple error remains unknown as the customer has decided not to order a repair for the device due to its age and numerous defect components.According to the instruction for use of the hl20 chapter "5.8.1 check before every application" the user has to ensure that the "clock" display shows no error messages.According to chapter ¿5.7.1 switching on the hl 20, self-test¿ when the device is tuned on the system control panel carries out a self-test and in the event of an error, the "clock" display shows the relevant error code.The review of the non-conformities has been performed on 2023-11-17 for the period of 2009-09-30 to 2023-11-01.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 2009-09-30.Based on the results the reported failure "the error message "beltslip" and ¿direct¿ on single pump and "overload" on the twin pump" could 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.
 
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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 Key18158190
MDR Text Key328368272
Report Number8010762-2023-00576
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 01/16/2024
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 NumberHL 20
Device Catalogue Number701043262
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2023
Initial Date FDA Received11/17/2023
Supplement Dates Manufacturer Received12/20/2023
Supplement Dates FDA Received01/16/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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