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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 02/19/2024
Event Type  malfunction  
Event Description
It was reported that a hl 20 a single roller pump and a twin pump displayed the error message "error head".The event occurred during a start up.No harm to any person has been 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.
 
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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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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key18748932
MDR Text Key335966446
Report Number8010762-2024-00097
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 Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number701028580
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/15/2018
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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