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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 10/12/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-10-13.The motor control boards for both pumps 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 2023-10-24 for the period of 2018-12-28 to 2023-10-12.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 2018-12-28.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that on the first pump the error message "safety-s" was displayed once and then it showed +5v test error continuously.The second pump did not switch on.The event occurred during a routine check.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that on the first pump the error message "safety-s" was displayed once and then it showed +5v test error continuously.The second pump did not switch on.The event occurred during a routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-10-13.The motor control boards for both pumps were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A similar case was already investigated by the getinge life cycle engineering on 2021-01-31.The most probable root cause of the detected "+5v test" could be determined to a faulty 5v power supply on the motor control board.The affected motor control board was not made available for further investigation.However with reference to the hl20 risk assessment (risk id: h1.1.1.2.6) this failure "safety-s" can be contributed to: wrong pump speed because of: - communication error (e.G.Wrong ratio between master-slave pumps due to communication error).The affected motor control board was not made available for further investigation.However the most probable root cause for the failure "pump not switching on" could be determined according to the risk management file as follows: (total) fail of device because of: - failure of motor, motor controller or control circuitry.- failure of pump control board (pump stop).- pump on/off defective.- defective tacho, relay or pump belt.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2018 to (b)(6) 2023.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 (b)(6) 2018.Based on the results the reported failure "safety-s, +5v test error and pump not switching on" 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
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 Key17998788
MDR Text Key326425302
Report Number8010762-2023-00521
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 11/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 20
Device Catalogue Number701043262
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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