Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CARDIOHELP-I
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2023
Event Type  malfunction  
Manufacturer Narrative
It was reported that he integrated pressure values for the hls would fluctuate and change when the hls cable was moved around in different directions.The failure occurred during treatment.No patient or operator harm was reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-11-06.The fst cleaned the connections which improved the pressure readings.The hls cable was replaced.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 failure could not be confirmed on the date of event, (b)(6) 2023, as there are no pressure values provided in the log files.According to the technician, the most probable root cause was contamination on the connections and hls cable damaged internally.Additionally, according to the risk file v24 of the cardiohelp device, the following root causes can 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.According to the instruction for use (ifu) 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 must 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.According to the 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.Additionally, in the ifu chapter 10 "cleaning and disinfection", the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in the ifu chapter 5.3 "connecting the sensors" it is stated that the sensors must be kept clean.The review of the non-conformities has been performed on 2023-10-24 for the period of 2017-04-26 to 2023-10-13.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 manufacture on 2017-04-26.Based on the results the reported failure "pressure values fluctuating" 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 he integrated pressure values for the hls would fluctuate and change when the hls cable was moved around in different directions.The failure occurred during treatment.No patient or operator harm was reported.Complaint id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18140554
MDR Text Key328982471
Report Number8010762-2023-00574
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
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 NumberCARDIOHELP-I
Device Catalogue Number701048012
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/06/2023
Initial Date FDA Received11/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-