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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  malfunction  
Manufacturer Narrative
It was reported that moving the pressure cable lead to negative pressure values, and an acoustic alarm when the pressure dropped below zero.The event occurred during treatment.No interventions related to pressure were set.No harm to any person was reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-10-24.The pressure cable was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected pressure cable was discarded.According to the getinge field service technician there were no visible damage at the pressure cable and the replacement did solve the reported failure "moving the pressure cable lead to negative pressure values".Therefore the most probable root cause could be determined as a loose connection in the pressure sensor cable.According to the instructions for use hl 20 version 02 in chapter 5.5.1 preparing pressure monitoring and inserting the pressure sensors: the user to use only a fully functional pressure monitoring module during the operation and always perform a complete function test with pressure sensor before use.The review of the non-conformities has been performed on 2023-11-08 for the period of 2015-11-12 to 2023-10-24.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 2015-11-12.Based on the results the reported failure "moving the pressure cable lead to negative pressure values" 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.
 
Event Description
It was reported that moving the pressure cable lead to negative pressure values, and an acoustic alarm when the pressure dropped below zero.The event occurred during treatment.No interventions related to pressure were set.No harm to any person was reported.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
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key18117761
MDR Text Key327873560
Report Number8010762-2023-00564
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 11/13/2023
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 Number701043266
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received11/13/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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