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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 Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2024
Event Type  malfunction  
Event Description
The event occurred in india during start up.It was reported that the hl20 cardioplegia pump stops intermittently.During inspection the error message "s-stop" and "ad-conv" were observed.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
The event occurred in india during start up.It was reported that the hl20 cardioplegia pump stops intermittently.During inspection the error message "s-stop" and "ad-conv" were observed.No harm to any person has been reported.A getinge field service technician will be sent for investigation and repair.As soon as new information becomes available a follow up medwatch will be submitted.
 
Manufacturer Narrative
The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2024-01-10.The odu pump socket with cabling, the odu pump plug with cabling and the pump control board were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2024-04-12 for the period of 2008-10-23 to 2024-01-13.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 2008-10-23.A follow-up medwatch will be submitted when additional information becomes available.
 
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
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18579729
MDR Text Key333776788
Report Number8010762-2024-00045
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 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number701029325
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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