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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 02/28/2024
Event Type  malfunction  
Event Description
It was reported that the hl20 roller pump module displayed the error message: "head" during routine check.No harm to any person has been reported.Since the error message: "head" can cause an unintentional pump stop, a report is required.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that the hl20 roller pump module displayed the error message: "head" during routine check.No harm to any person has been reported.Since the error message: "head" can cause an unintentional pump stop, a report is required.A getinge field service technician will be sent onsite for investigation and repair.As soon as new information becomes available a follow up medwatch will be submitted.
 
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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 Key18876325
MDR Text Key337342455
Report Number8010762-2024-00133
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,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number70102.8580
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2011
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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