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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 02/12/2024
Event Type  malfunction  
Event Description
It was reported that the hl20 pump displayed the error message: ¿runaway¿ and that a pump cover clip was broken.The event occurred during a routine check.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.
 
Event Description
It was reported that the hl20 pump displayed the error message: ¿runaway¿ and that a pump cover clip was broken.The event occurred during a routine check.After the "runaway" error was resolved the error message "safety-s" was reported.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that the hl20 pump displayed the error message: ¿runaway¿ and that a pump cover clip was broken.The event occurred during a routine check.After the "runaway" error was resolved the error message "safety-s" was reported.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2024-02-12, 2024-02-15 and 2024-02-24.The runaway error was resolved by cleaning the tacho strobe.The safety-s error was resolved by refitting of all circuit board connections.No parts were replaced in regards to this failures.The broken cove clip was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The most probable root cause for the failure "runaway" error was determined as contamination on the tacho strobe, since cleaning of the tacho strobe did solve the failure.A similar case was assessed by the getinge life cycle engineering on 2024-03-04.Because the error "safety-s" was resolved by refitting of all circuit board connections the most probable root cause was determined as communication disturbances due to transition resistance that can arise from surface corrosion.The damaged pump cover clip can be linked to the following most possible root causes according to the hl 20 risk assessment: housing damaged because of: mechanical impact.Rough handling.Operation/ transport/ storage under wrong (environmental) conditions.Wrong cleaning/ disinfection process and/ or substance.Aging of material (manufactured 2007-04-04).The review of the non-conformities has been performed on 2024-02-15 for the period of 2007-04-04 to 2024-02-12.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 2007-04-04.Based on the results the reported failure "runaway, safety-s and broken pump cover clip" 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.
 
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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
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18719577
MDR Text Key336641009
Report Number8010762-2024-00090
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 03/25/2024
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 Number701043262
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2024
Initial Date FDA Received02/16/2024
Supplement Dates Manufacturer Received03/15/2024
Supplement Dates FDA Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2018
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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