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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CARDIOHELP-I
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2023
Event Type  malfunction  
Manufacturer Narrative
A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that the cardiohelp stopped pumping.The customer could not get the cardiohelp to do anything and then the device started to work again.As the patient was on an impella pump which enabled the customer to maintain blood pressure/flow, no harm to any person has been reported.Complaint id (b)(4).
 
Manufacturer Narrative
It was reported that the cardiohelp stopped pumping.The customer could not get the cardiohelp to do anything and then the device started to work again.As the patient was on an impella pump which enabled the customer to maintain blood pressure/flow, no harm to any person has been reported.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair on 2023-12-02 and 2024-01-05/09.No part was replaced.The cardiohelp device was tested for a month at 3200 rpm and no failure occurred.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the message "pump stopped" could be confirmed on the date of event.The exact root cause remains unknown, as the failure was not reproducible.However, according to getinge technical support the most probable root cause is a hmi software hung and therefore the cardiohelp restarted.This is considered as a sporadic one-off error.Referring to the instruction for use (ifu) chapter of the affected cardiohelp device, chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.The review of the non-conformities has been performed on 2024-01-10 for the period of 2020-09-24 to 2023-11-20.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 2020-09-24.Based on the results the reported failure "pump stopped" 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
CARDIOHELP
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 Key18199690
MDR Text Key328897233
Report Number8010762-2023-00585
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCARDIOHELP-I
Device Catalogue Number701072780
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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