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 12/08/2023

Event Type  malfunction  

Event Description

It was reported that the sensor control board got scratched when removing metal harness lock from connector.Additionally, during inspection it was found that the external integrated pressure connector was not working.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

During regular maintenance the sensor control board got scratched by the getinge technician when removing metal harness lock from connector.Then it was found that the external integrated pressure connector was not working.No harm was reported to any person.The sensor panel was replaced.Safety, calibration, and functionality checks were performed according to factory specifications.All function tests are passed.The fst confirmed that the root cause of the failing pressure connector was the damaged sensor panel which in return was scratched by accident during service when removing metal harness lock from the connector.With this new information this customer complaint is no longer reportable as the risk is remote.This failure of pressure connector was related to the damage of sensor panel by the service technician, which would be detected always during the same situation.As stated in the service manual of the cardiohelp device (cardiohelp system, service requirements) only authorized service technicians are allowed to carry out service-related work.Thus the issue can only occur during service of an authorized service technician.Further according to chapter 3.1 "general information" the device has to be checked after every maintenance or repair.Further, 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 2023-02-23.The device history record (dhr) of the cardiohelp was reviewed on 2024-02-15.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failures.Based on the results the reported failures "external integrated pressure connector not functional" and "scratched sensor panel during service" could be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device and the failure "external integrated pressure connector not functional" due to the root cause "sensor panel damaged" as a single event (timeframe from (b)(6) 2023.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

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: 18324270
• MDR Text Key: 330480127
• Report Number: 8010762-2023-00622
• 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,Followup
• Report Date: 02/22/2024

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
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1