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

Model Number CARDIOHELP.I

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair.The emergency drive board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that one light of the speed indicator on the emergency drive is out.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that one light of the speed indicator on the emergency drive is out.There was no visible damage on the speed indicator or emergency drive.The failure was found during preventive maintenance.The serial number for the related cardiohelp is not available due to the fact that only the emergency drive was sent to depot repair.A getinge field service technician (fst) investigated.The emergency drive board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A similar failure was already investigated by getinge life-cycle-engineering on 2018 (b)(6) with following conclusion: the inductance l1 has an internal crack.Possible root causes could be external mechanical stress.In the instruction for use of the cardiohelp device (chapter 5.6.1 "check before every application") it is stated that the emergency drive must be checked before use.Based on the results the reported failure "one light of the emergency drive speed indicator out" 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: 18418043
• MDR Text Key: 331584157
• Report Number: 8010762-2023-00650
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1