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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 Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2023
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 there was a pressure reading issue.It was reported that the pressure line does not read the post membrane pressure.No harm to any person has been reported.Complaint id #: (b)(4).
 
Event Description
Complaint id # (b)(4).
 
Manufacturer Narrative
It was reported that there was a pressure reading issue.It was reported that the pressure line, hls cable, does not read the post membrane pressure.The failure occurred during treatment.The hls set was transferred to a different cardiohelp unit.A getinge field service technician (fst) was sent for investigation and repair on 2024 (b)(6).The hls cable was replaced.The fst confirmed that there was a pressure reading issue.Additionally, the fst confirmed that the defective hls cable did not have any contamination on the connectors.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.No pump stop or sensor defective/disconnected could be found on the date of event, 2023-12-28.A similar failure was investigated by the life cycle engineering on 2020 (b)(6).According to investigation report, the nature of the error could be traced back to a missing electrical connection within the cable.The root cause for the missing connection is a broken wire within the cable, which originated from external force.Additionally, according to the risk analysis v23, following root causes can also lead to the reported failure: a mechanical damage e.G.Due to too high forces during connection/ disconnection of the cable.Broken fiber inside the cable.In the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) the pressure sensors have to be calibrated and checked before priming.Furthermore, the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.Moreover, in the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.The review of the non-conformities has been performed on 2024 (b)(6) for the period of 2015 (b)(6) to 2023 (b)(6).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 2015-09-02.Based on the results the reported failure " pressure reading issue" 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
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 Key18424398
MDR Text Key331784347
Report Number8010762-2024-00005
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 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCARDIOHELP-I
Device Catalogue Number701048012
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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