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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 06/20/2022
Event Type  malfunction  
Manufacturer Narrative
It was reported that the hl20 device had a malfunction prior to use.The pumps were routinely turned on to check whether each pump was working.After the double head pump with sn#(b)(4) was turned on for 1 minute the error message: "errhead" was reported.After that the pump was not used for the operation and was exchanged prior to the treatment.No injury or harm to any person reported.A getinge field sevice technician will be sent onsite for 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 device had a malfunction prior to use.The pumps were routinely turned on to check whether each pump was working.After the double head pump with sn#(b)(4) was turned on for 1 minute the error message: "errhead" was reported.After that the pump was not used for the operation and was exchanged prior to the treatment.No injury or harm to any person reported.Reference number: (b)(4).
 
Event Description
Ref#(b)(4).
 
Manufacturer Narrative
It was reported that the hl20 was malfunctioning before the operation and it was routinely turned on to check whether each pump was working.No patient was involved.One double head pump was turned on and displayed the error message: "head" after it was turned on for 1 minute.After that the pump was no longer used.The customer stated that the double-head pump was later turned on normally and no service was requested.Thus the reported failure could not be confirmed.However the failure mode "head error" can be linked to the following most possible root causes according to the hl 20 risk management file (dms# 2023585, version 11): failure of pump control board.Defective/ dirty tacho, relay or pump belt.The device in question was manufactured on 2017-09-26.The review of the non-conformities during the period of 2017-09-26 to 2022-06-21 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 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
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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hechingen
Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key14849436
MDR Text Key303231925
Report Number8010762-2022-00251
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeCH
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 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number70103.3557
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/21/2012
Is the Device Single Use? No
Type of Device Usage A
Patient Sequence Number1
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