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

Model Number CARDIOHELP-I

Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that the rpm speed display is not working on the hls drive.The failure occurred during inspection by getinger technician.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

This complaint # (b)(4) was initially reported as led foil of the e-drive was affected.However, after investigation it was corrected and confirmed that the speed indicator on top of the cardiohelp was defective and therefore the led foil of the e-drive was not affected.Thus, this event is now considered to be a non-reportable incident due to the investigation below: the failure occurred during inspection by getinge technician.A getinge field service technician (fst) was sent for investigation and repair on.The fst determined that the signal wires of the speed display were disconnected.The wires were repaired and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.As found by the fst during service, the root cause were signal interference due to loose signal of the wires.Further, according to the risk file v24 of the cardiohelp (dms# 2021972) following is mentioned as a root cause - defective led speed indicator additionally, according to getinge technical experts, the led foil cannot be investigated.The led foil is glued to the housing of the cardiohelp and is therefore destroyed during disassembly.According to the instruction for use (ifu) of the cardiohelp, chapter 3.3.1 ¿led speed indicator¿ the speed indicator led on the top of the cardiohelp displays the speed independently of the touchscreen.In case of a failure of this component, the speed can be still observed by the user on the touchscreen according to ifu ¿chapter 3.7.5 parameter display¿.It is stated in the instruction for use (cardiohelp system, chapter 5.6.1 check before every application) that the speed indicator led and the touchscreen have to be checked before use.Thus, no report is required for this failure.Based on the results the reported failure "speed indicator on top of the cardiohelp does not work" 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: 18325072
• MDR Text Key: 330486703
• Report Number: 8010762-2023-00620
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• 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: 01/31/2024

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: 12/07/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1