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 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported that the venous bubble detector was alarming and could not be cleared/silenced.The customer removed the venous bubble detector and attached one from another cardiohelp.The new venous bubble detector was able to be re-set, and it stopped alarming.The patient was never off support, and there were no adverse affects.No harm to any person has been reported.Complaint id:(b)(4).

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

It was reported that the venous bubble detector was alarming and could not be cleared/silenced.The customer removed the venous bubble detector and attached one from another cardiohelp.The new venous bubble detector was able to be re-set, and it stopped alarming.The event occurred during treatment and the patient was never off support, and there were no adverse affects.A getinge field service technician (fst) investigated the cardiohelp in the depot center on (b)(6) 2024.The defective venous bubble sensor was not shipped with the cardiohelp.Thus, the failure could not be replicated.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp were reviewed and the error messages "venous bubble sensor defective" and "venous bubble sensor disconnected" could be confirmed multiple times on the date of event, 2023-10-30.As the venous bubble sensor was not available for investigation, an exact root cause could not be identified.However, according to the risk file v24 of the cardiohelp the following root causes can lead to the reported failure: - wrong bubble sensor information - influence due to other ultrasonic devices (e.G.Flow sensor) - bubble sensor disturbed - bubble sensor not plugged but recognized - connection of non-compatible sensor - environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage) according to the instructions for use (ifu), chapters 2.2.5 "monitoring and sensors" and 5.4.4 "bubble monitoring: function test" the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The venous bubble sensor is optional and for additional bubble detection.In the ifu of the cardiohelp (chapter 10 "cleaning and disinfection", the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in chapter 5.3 "connecting the sensors", it is stated that the sensors must be kept clean.The device was manufactured on 2013-07-29.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2023 to (b)(6) 2023.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.Based on the results the reported failure "venous bubble detector was alarming and could not be cleared/silenced" could be confirmed within the log files, but not reproduced by fst.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.Note: the pressure failure was investigated within the already opened complaint#(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: 18071953
• MDR Text Key: 327376580
• Report Number: 8010762-2023-00541
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 701048012
• Device Lot Number: 3000299601
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1