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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 Problems Component or Accessory Incompatibility (2897); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
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 displayed on the cardiohelp and the pressure displayed on external pressure monitor was inconsistent.The failure occurred during treatment.No harm to any person has been reported.Complaint id # (b)(6).
 
Event Description
Complaint id # (b)(4).
 
Manufacturer Narrative
It was reported that there was a pressure reading issue.It was reported that the pressure displayed on the cardiohelp and the pressure displayed on external pressure monitor was inconsistent.The external pressure monitor was replaced, however, there was still a large difference between the displayed pressure on the cardiohelp and the replacement eternal pressure monitor.The cardiohelp was not exchange.There were no adverse effects on the patient.The failure occurred during treatment.A getinge field service technician (fst) was contacted by the customer.No parts were replaced.According to the fst, the cardiohelp had no reported failure.(refer to communications grid).The log files of the reported cardiohelp device were requested but could no be provided.No exact root cause could be determined.According to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: wrong plugged external pressure sensor or disconnection (mix up); defective / disturbed (emi) pressure sensor; connection of non-compatible sensor.According to 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.The device was manufactured on 2023-07-21.The device history record (dhr) of the cardiohelp was reviewed on 2023-12-01.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "inaccurate pressure" could not 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 Key18158157
MDR Text Key328364236
Report Number8010762-2023-00575
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133598
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 12/08/2023
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 11/14/2023
Initial Date FDA Received11/17/2023
Supplement Dates Manufacturer Received12/01/2023
Supplement Dates FDA Received12/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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