MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP

Device Problems Communication or Transmission Problem (2896); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

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 initially reported that the device had a loose contact and could not be used.Subsequently, it was reported that the internal arterial pressure was -500.The failure occurred during treatment.The values could be improved by plugging and unplugging the hls cable.No harm to any person has been reported.Complaint id # (b)(4).

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

It was initially reported that the device had a loose contact and could not be used.Subsequently, it was reported that the internal arterial pressure was -500.The values could be improved by plugging and unplugging the hls cable.The failure occurred during treatment and the cardiohelp was exchanged.A getinge field service technician (fst) was sent for investigation.The fst confirmed that the pressure failure was related to the corrosion within the female connectors of the sensor panel.The sensor panel 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 no pump stops were observed on the date of event.According to the fts, the root cause was contamination in the female connector of the sensor panel.A similar issue was already investigated by the getinge life cycle engineering.Deposit was detected on the cable socket during visual inspection.The most probable root cause was determined as wetting of the socket plane of the plug with salt-containing liquids (priming).A service bulletin (issue 95 / 21-05-04) was published may 2021 to make the users aware that the contacts of the plug connections must not come into contact with cleaning agents, disinfectants or priming liquid.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.In the instruction for use (ifu) of the cardiohelp, chapter "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 of the cardiohelp (chapter ¿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 "connecting the sensors" it is stated that the sensors must be kept clean.According to the ifu of the cardiohelp system, chapter ¿connecting the sensors¿, any connections that are not in use shall be protected with the supplied protective caps.Additionally, in the ifu, chapter ¿check before every application¿, it is stated that the device shall only be used after every function test prior to use has been passed.Furthermore, in the ifu, chapter ¿surface cleaning and disinfecting after each use¿, it is stated that the device shall only be cleaned with a damp cloth without using chemical solvents or spilling anesthetics.The device shall not be sprayed with liquids.The review of the non-conformities has been performed on 2024-03-18 for the period of 2017-03-16 to 2024-02-26.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 2017-03-16.Based on the results the reported failure ¿pressure reading issue due to contaminated sensor panel" 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.

• 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 Key: 18864384
• MDR Text Key: 337192212
• Report Number: 8010762-2024-00127
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1