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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The error message "ven.Bubble sensor defective" was reported.A getinge technician investigated the cardiohelp on (b)(6) 2020 and could confirm the reported failure.The venous bubble sensor was replaced.The unit passed all tests after repair and was cleared for clinical use.Work performed on (b)(6) 2020.Another venous bubble sensor with the same issue was already investigated by life cycle engineering (lce) and the supplier (b)(6) on (b)(6) 2020.Following possible root causes were determined: damaged cable due to mechanical tension.Damage due to overvoltage or esd (electrostatic discharge).Based on the investigation results the reported failure""ven.Bubble sensor defective" could be confirmed.The occurrence rate was calculated for the reported failure 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

The customer reported that the cardiohelp would alarm with "ven.Bubble sensor defective".Occurred during patient treatment and the sensor was swapped with another one to solve the issue during use.(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: 12330845
• MDR Text Key: 266863468
• Report Number: 8010762-2021-00450
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1