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

Model Number CARDIOHELP.I

Device Problem Failure to Read Input Signal (1581)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that the connection cable for disposables was defective, causing the pressure readings to be incorrect and fluctuating.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the cable for disposables (hls cable) was defective which resulted in wrong pressure value readings.The failure occurred during priming.A getinge field service technician (fst) was sent for investigation and repair.The failure could be traced back to the connection cable for disposables, which was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The exact root cause remains unknown.However, similar failures with a variety of causes were investigated in the past: another disposable connection cable with a similar failure was investigated by getinge life cycle engineering on 2021-03-31.Deposit and oxides were found on the cable socket.By wetting the socket plane with salt-containing liquids (priming), the measurement signals were influenced by the electrical conductivity of the contamination.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.Additionally, another disposable connection cable with a similar failure was investigated by getinge life cycle engineering (lce) on 2022-11-02.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 is originated from external force.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.Further, it is stated in the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", 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 2023-12-18 for the period of 2016-08-19 to 2023-11-13.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 manufactured on 2016-08-19.Based on the results the reported failure "pressure readings wrong due to hls cable" 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: 18382079
• MDR Text Key: 331222845
• Report Number: 8010762-2023-00642
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• 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: 12/22/2023

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 Number: CARDIOHELP.I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1