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

Model Number CARDIOHELP-I

Device Problems Failure to Sense (1559); Pressure Problem (3012)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported that the cardiohelp unit did not allow pressures to be zeroed and that the device was used in the emergency mode.No harm to any person has been reported.The serial number and catalog number of the affected cardiohelp were not yet reported.Complaint id: (b)(4).

Manufacturer Narrative

A getinge technician will investigate the cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that during patient transport the cardiohelp did not allow pressures to be zeroed, because the touch panel was not responding.The device was used in the emergency mode during transport and was exchanged when the patient arrived.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2022-12-05, 2022-12-06, 2022-12-07 and 2023-02-02.The user interface hardware update kit was replaced.The rotary encoder was replaced as a precaution.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files analysis on 2023-02-20 does not show any malfunction of the cardiohelp.The failure "touch panel is not responding" has been previously acknowledged and actions have been implemented to avoid the reoccurrence of the issue.The touch panel foil (material#70505.3579_rev.02) which was used formerly showed an increased rate of connection problems.As a solution for that a new touch panel was implemented and is built in cardiohelp units since september, 2019.In regards to the replacement of this part a service bulletin (issue 82 / 2019-09-25) was provided to the sales and service units.The cardiohelp has several safety features, that the device can be operated, even when the touch screen does not work anymore.All-important adjustments can be made by using the rotary knob or if all other things do not work by engaging the emergency mode to keep up the blood flow.Further, according to the instruction for use the touch screen has to be checked before use.Thus the risk for harm of any person is remote.The product in question was produced on 2018-07-02.Based on the results the reported failure "touch panel was not responding" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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 during patient transport the cardiohelp did not allow pressures to be zeroed, because the touch panel was not responding.The device was used in the emergency mode during transport and was exchanged when the patient arrived.No harm to any person has been reported.Complaint id: (b)(4).

• 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: 15435469
• MDR Text Key: 300573316
• Report Number: 8010762-2022-00374
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: REQUESTED
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1